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Articles de revues sur le sujet « USFDA »

Auteur : Grafiati

Publié le 2 juin 2025

Mis à jour le 31 juillet 2025

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1

Chahal, Harinder Singh, Peter Capella, Ryan Presto, et al. "Impact of the US Food and Drug Administration registration of antiretroviral drugs on global access to HIV treatment." BMJ Global Health 3, no. 3 (2018): e000651. http://dx.doi.org/10.1136/bmjgh-2017-000651.

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BackgroundSince 2004, the US Food and Drug Administration’s (USFDA) dedicated drug review process in support of President’s Emergency Plan for AIDS Relief (PEPFAR) has made safe, effective and quality antiretrovirals (ARVs) available for millions of patients. Furthermore, the WHO and Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) can add the USFDA-reviewed products to their respective formularies, through a novel process of ‘one-way reliance’. We assessed the number of ARVs made available through WHO and Global Fund based on the USFDA review.MethodsWe conducted a cross-secti

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Imran, Mohd, Syed Mohammed Basheeruddin Asdaq, Shah Alam Khan, et al. "Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades." Pharmaceuticals 14, no. 8 (2021): 710. http://dx.doi.org/10.3390/ph14080710.

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Protein kinase inhibitors (PKIs) are important therapeutic agents. As of 31 May 2021, the United States Food and Drug Administration (USFDA) has approved 70 PKIs. Most of the PKIs are employed to treat cancer and inflammatory diseases. Imatinib was the first PKI approved by USFDA in 2001. This review summarizes the compound patents and the essential polymorph patents of the PKIs approved by the USFDA from 2001 to 31 May 2021. The dates on the generic drug availability of the PKIs in the USA market have also been forecasted. It is expected that 19 and 48 PKIs will be genericized by 2025 and 203

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Yogesh, M. Binnar. "Warning Letter: Cause and Remedy in Pharmaceutical Industry." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1069–75. https://doi.org/10.5281/zenodo.11234707.

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The abstract summarizes the critical findings and gaps identified in scholarly research concerning USFDA inspections and warning letters issued to pharmaceutical facilities in India over the past thirteen years. It highlights the lack of detailed explanation and understanding of the six-step inspection model employed by USFDA inspectors during facility audits. Additionally, the abstract points out a perceived increase in the expectations of USFDA inspectors, with a trend towards more thorough and in-depth scrutiny of pharmaceutical operations. However, there appears to be a lack of awareness a

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Meesters, Roland JW, and Stephan Voswinkel. "Bioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry." Journal of Applied Bioanalysis 4, no. 3 (2018): 67–73. http://dx.doi.org/10.17145/jab.18.010.

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Dr., S. D. Mankar Kalyani Nikam* Vaishnavi Palve Vaishnavi Nirmal Pallavi Palve Jagdish Nikam. "USFDA Guidelines: A review on Pharmaceuticals Formulations." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 1473–79. https://doi.org/10.5281/zenodo.15201903.

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Ensuring Quality in Pharmaceutical Manufacturing should follow ISO9001:2015 Standards and guidelines from regulatory bodies like the FDA, EMA, WHO. To ensure product quality, safety and efficacy which require process validation to guarantee the quality of their products. This applies to both finished drugs and active pharmaceutical ingredients (APIs). The Goal of Quality is the primary objective of Quality Control can produce medications that are secure and essential for their intended use. Process validation involves collecting and analyzing data throughout the manufacturing process, from des

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Kshatriya, Garima, and Dilip G. Maheshwari. "A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India." International Journal of Drug Regulatory Affairs 6, no. 2 (2018): 1–7. http://dx.doi.org/10.22270/ijdra.v6i2.227.

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Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending their qualification which would expedite the drug development process. This qualification would ensure better understanding of drug targets and long term safety outcomes. Regulatory authorities of Europe, Japan & India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.

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Boyer, Ivan J., Wilma F. Bergfeld, Bart Heldreth, Monice M. Fiume, and Lillian J. Gill. "The Cosmetic Ingredient Review Program—Expert Safety Assessments of Cosmetic Ingredients in an Open Forum." International Journal of Toxicology 36, no. 5_suppl2 (2017): 5S—13S. http://dx.doi.org/10.1177/1091581817717646.

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The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with pr

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Jaiswal, Sandhya, Parshant Sharma, and Heena Qureshi. "A Comparative Study of Regulations of Nasal Products in the US and EU." International Journal of Drug Regulatory Affairs 11, no. 1 (2023): 15–23. http://dx.doi.org/10.22270/ijdra.v11i1.573.

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A study relating to the regulation for nasal products has been conducted for the current review. The analysis emphasized the significance of classifying nasal products. Nasal products are challenging to manufacture in India due to regulatory and logistical issues. In addition to the production guidelines established by the USFDA and EU, the study analyses the prospects for nasal products in the future. Some common policies held by the 2 major international agencies have been shown in this review. The current evaluation focuses on how nasal product production should be done in conjunction

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Hudu, Shuaibu A., Fayig Elmigdadi, Aiman Al Qtaitat, et al. "Trofinetide for Rett Syndrome: Highlights on the Development and Related Inventions of the First USFDA-Approved Treatment for Rare Pediatric Unmet Medical Need." Journal of Clinical Medicine 12, no. 15 (2023): 5114. http://dx.doi.org/10.3390/jcm12155114.

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Rett syndrome (RTT) is a rare disability causing female-oriented pediatric neurodevelopmental unmet medical need. RTT was recognized in 1966. However, over the past 56 years, the United States Food and Drug Administration (USFDA) has authorized no effective treatment for RTT. Recently, Trofinetide was approved by the USFDA on 10 March 2023 as the first RTT treatment. This article underlines the pharmaceutical advancement, patent literature, and prospects of Trofinetide. The data for this study were gathered from the PubMed database, authentic websites (Acadia Pharmaceuticals, Neuren Pharmaceut

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Sharma, Akash, Vriti Gamta, and Gaurav Luthra. "Regulatory Compliance in the United States: A Comprehensive Analysis of USFDA Guidelines and Implementation Strategies." Journal of Pharmaceutical Research International 35, no. 17 (2023): 41–50. http://dx.doi.org/10.9734/jpri/2023/v35i177389.

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This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this re

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Rajendra, Mogal* Madhavi shinde Ashwini Shelke Rahul Sable Anil Jadhav. "APPLICATIONS OF SIMULTANEOUS EQUATION METHOD FOR THE DETERMINATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TO DISSOLUTION STUDIES IN MARKETED TABLETS." Indo American Journal of Pharmaceutical Sciences 04, no. 10 (2017): 3650–54. https://doi.org/10.5281/zenodo.1035796.

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The main objective of present work was to develop simple spectrophotometric multicomponent method of analysis i. e. simultaneous equation method. Tenofovir disoproxil fumarate & Emtricitabine was first approved in US in July 2003 and is indicated for adults aged > or =18 years. This method is used for dissolution study of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form. As per USFDA guidelines, dissolution study was carried out in 900 mL 0.01 N HCl. Dissolution study was carried out using a USP Type 2 (Paddle) apparatus at a stirring rate of 50 rpm for 45

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Zhang, Chao, Yue Ma, Xiao Yan Zhao, and Fen Wang. "Effect of Drying Treatments on Anthocyanin, Fumonisin B₁, Aflatoxin B₁ Content of Anthocyanin Extract from Purple Corn (Zea may L.) in North China." Advanced Materials Research 335-336 (September 2011): 1396–401. http://dx.doi.org/10.4028/www.scientific.net/amr.335-336.1396.

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Effects of drying treatments on anthocyanin, fumonisin B1, aflatoxin B1content of anthocyanin extract from purple corn were evaluated based on the harvest of 2008 and 2009 in north China. The anthocyanin content of anthocyanin extract from husk was 62.4 g/kg, being significant higher than that from cob and seed. The fumonisin B1and aflatoxin B1content of anthocyanin extract from the husk were 4.25 and 5.60 μg/kg, respectively, according with legislative limitation of USFDA. Moreover, the fumonisin B1and aflatoxin B1content of anthocyanin extract from the husk were lower than the maximum limita

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Almutairi, R., V. Sanogo, and K. Diaby. "CO51 Safety Profile of Approved Alzheimer's Medication By USFDA." Value in Health 26, no. 12 (2023): S23. http://dx.doi.org/10.1016/j.jval.2023.09.123.

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Munesh, Ganesha, and Madhavi Lakshmi Ratna Bhavaraju. "Regulatory framework for USFDA regulated drug product labeling update." Pharmaceutical Sciences Asia 51, no. 1 (2024): 10–18. http://dx.doi.org/10.29090/psa.2024.01.23.731.

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Abhishek, Chakraborty. "A Descriptive Study of the Regulations of Leachable and Extractables of US, Europe and Canada." International Journal of Pharmaceutics & Pharmacology 2, no. 2 (2018): 1–15. https://doi.org/10.31531/2581-3080.1000129.

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<em>Leachables and extractables are one of the most important reasons for drug product quality deterioration and degradation. These components tend to migrate from the interior regions of the packaging material to the drug product by causing interactions, due to absorption or adsorption of the same on the Drug Product. The USFDA, EU and Health Canada laid down specific non-exhaustive regulation and guidelines that are to be followed in mandatory to attain drug approvals from these regulated regions. The USFDA, in its recent revision of its ANDA (Abbreviated New Drug Application) checklist, has

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Zhang, Chao, Yue Ma, Xiao Yan Zhao, and Fen Wang. "Effect of Storage Treatments on Anthocyanin, Fumonisin B₁, Aflatoxin B₁ Content of Anthocyanin Extract from Purple Corn (Zea may L.) in North China." Advanced Materials Research 361-363 (October 2011): 759–63. http://dx.doi.org/10.4028/www.scientific.net/amr.361-363.759.

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Effects of storage treatments on anthocyanin, fumonisin B1, aflatoxin B1 content of anthocyanin extract from purple corn were evaluated based on the harvest of 2008 and 2009 in north China. The anthocyanin content of anthocyanin extract from husk was 62.4 g/kg, being significant higher than that from cob and seed. The fumonisin B1 and aflatoxin B1 content of anthocyanin extract from the husk were 4.25 and 5.60 μg/kg, respectively, according with legislative limitation of USFDA. Moreover, the fumonisin B1 and aflatoxin B1 content of anthocyanin extract from the husk were lower than the maximum

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Satheesh, S., S. Abimanyu, and R. Kamaraj. "Regulatory Challenges of Sterile Formulation Development As Per USFDA Prospectives." Research Journal of Pharmacy and Technology 13, no. 3 (2020): 1511. http://dx.doi.org/10.5958/0974-360x.2020.00275.9.

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P. S, Sivaranjani, Priyadharshini S, and Nagalakshmi S. "Navigating Digital Health Technology: A Comprehensive Review of USFDA Regulations." Journal of Advances in Medical and Pharmaceutical Sciences 26, no. 10 (2024): 1–11. http://dx.doi.org/10.9734/jamps/2024/v26i10716.

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Digital health technology is revolutionizing the healthcare landscape by leveraging digital and information technologies to enhance healthcare delivery, monitoring and management. This technology encompasses a wide range of tools, including mobile apps, wearable, telemedicine, electronic health records, and AI-driven diagnostics. Digital health technologies may be beneficial but also problematic. Development requires navigating complicated regulatory systems and meeting changing criteria. These technologies, particularly those using AI algorithms, need robust clinical validation to prove their

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Kumar, T. Sudheer, and Raju Kamaraj. "Compliance challenges in clinical research organizations: A USFDA inspection retrospective." Journal of Pharmacy & Pharmacognosy Research 12, no. 1 (2024): 91–98. http://dx.doi.org/10.56499/jppres23.1782_12.1.91.

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Context: Clinical research plays a vital role in advancing medical knowledge and improving patient care. As regulatory bodies strive to ensure the integrity and safety of clinical trials, the US Food and Drug Administration (USFDA) conducts inspections to evaluate compliance with established regulations. Aims: To examine the USFDA's inspections and non-compliance actions taken against clinical research organizations (CROs) over a 13 years period. Methods: The study utilizes a comprehensive dataset compiled from publicly available records, including inspection reports, warning letters, and othe

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Manisha, B. Divraniya1 Maitreyi Zaveri2 Zuki Patel*3. "Optimizing RTR (Refuse To Receive) Filing For Enhanced Regulatory Compliance In Pharmaceutical Submission And Briefing The Analysis Of The USFDA ECTD Publishing." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1866–72. https://doi.org/10.5281/zenodo.11403389.

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The pharmaceutical industry faces stringent regulatory requirements, particularly concerning the submission of Electronic Common Technical Documents (eCTD) to the United States Food and Drug Administration (USFDA). A critical aspect of this process is the Refuse to Receive (RTR) filing, wherein submissions may be rejected due to non-compliance with regulatory standards. This article presents an in-depth exploration of optimizing RTR filing procedures to ensure enhanced regulatory compliance and expedited approval timelines. Through a thorough analysis of USFDA eCTD publishing guidelines and be

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Amaravadi, Divya, Sravya Guptha, and Rama Rao Tadikonda. "Pregnancy Related Medication Prescription Patterns." International Journal of Medical Sciences and Pharma Research 10, no. 3 (2024): 1–5. http://dx.doi.org/10.22270/ijmspr.v10i3.101.

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Introduction: Drug use during pregnancy presents significant challenges due to altered pharmacokinetics and pharmacodynamics, with potential adverse effects on the fetus. The USFDA (United States Food and Drug Administration) categorizes drugs from A to X based on their safety in pregnancy, guiding appropriate drug use. Hence, this research aimed to assess rationality in prescription pattern and to identify commonly prescribed medications in pregnant women. Methodology: A pilot prospective observational study was conducted for three months at Gandhi Hospital, Secunderabad. Women of any gestati

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Christopher, Devasahayam J., Narmada Ashok, Aruna Ravivarma, et al. "Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial." Allergy & Rhinology 9 (January 2018): 215265671879674. http://dx.doi.org/10.1177/2152656718796746.

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Background Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts. Methods A randomized comparison trial of Indian manufactured and USFDA-approved extracts of Dermatophagoides pteronyssinus (DP) and Dermatophagoides farinae (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare

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Rajueni, Khujith, and Mohua Chakraborty Choudhury. "Assessment of the availability of repurposed orphan drugs in India." PLOS Global Public Health 3, no. 9 (2023): e0001498. http://dx.doi.org/10.1371/journal.pgph.0001498.

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India has a massive burden of rare diseases (RDs), with an estimated 96 million people living with RDs but limited options for treatment. Repurposing drugs used for other common conditions are essential alternative for RDs due to their cost-effectiveness and reduced timeline. India’s patent regime prevents the evergreening of drugs, and a large generic manufacturing industry provides ample opportunity to explore the potential of repurposed drugs for treating RDs, known as repurposed orphan drugs (ROD). However, there is no portal or other source for information on orphan drugs in India. This s

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Mishra, Gaurav, Amisha Thakur, and Sukhbir Kaur. "Process Validation of Metformin Hydrochloride Tablet (500 mg) according to USFDA." Biological Sciences 01, no. 01 (2022): 07–08. http://dx.doi.org/10.55006/biolsciences.2021.1102.

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Jahangir, MA, SS Imam, I. Kazmi, and A. Muheem. "Type 2 Diabetes Current and Future Medications: A Short Review." International Journal of Pharmaceutics & Pharmacology Volume 1, Issue 1 (2017): 101. https://doi.org/10.5281/zenodo.1156225.

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<em>Diabetes Mellitus (DM) is a complex set of disease. It is basically a metabolic disorder in which body is unable to make enough insulin or it is not able to use insulin effectively or in some instances both. According to global report on diabetes released by World Health Organization, Geneva 422 million people suffers from diabetes in 2014. The number is expected to increase to 552 million by 2030.  A number of researches are going on around the globe by pharmaceutical companies to exploit the huge market it provides. This short review covers the brief basics of DM and its classificat

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Ashara, Kalpesh C., Vishal P. Mendapara, Nitin M. Mori, and J. K. Badjatya. "SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE." International Journal of Drug Regulatory Affairs 2, no. 3 (2018): 52–61. http://dx.doi.org/10.22270/ijdra.v2i3.142.

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In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review article.

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Rajat, Garg Anuj Garg. "DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR TACROLIMUS IN BULK AND MARKETED GEL." Turkish Journal of Physiotherapy and Rehabilitation 32, no. 3 (2021): 41116–72. https://doi.org/10.5281/zenodo.6973281.

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Tacrolimus (FK506) is a calcineurin inhibitor and immunosuppressant. It has the chemical formula C<sub>44</sub>H<sub>69</sub>NO<sub>12</sub> and is a 23-membered macrolide lactone. (Figure 1) that was discovered for the first time in 1987 in <em>Streptomyces tsukubaensis</em>. The US Food and Drug Administration (USFDA) originally approved it for liver transplantation in 1994.

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Adhao, Vaibhav S., Jaya P. Ambhore, Anant D. Bhuskat, and Dishali V. Talokar. "Comparative in-Vitro dissolution study of some sitagliptin generic tablets under biowaiver conditions by UV-Spectroscopy." Current Trends in Pharmacy and Pharmaceutical Chemistry 6, no. 3 (2024): 114–21. http://dx.doi.org/10.18231/j.ctppc.2024.025.

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The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from different manufacturers using in-vitro dissolution study under biowaiver conditions through UV Spectroscopy, and compare them with the innovator brand. The dissolution media consisted of three different buffers with varying pH levels, including HCl Buffer pH 2.0, Phosphate Buffer pH 4.0, and Phosphate Buffer pH 7.2. The dissolution process was conducted using a USP type-2 dissolution apparatus with a 900 ml basket. The rotational speed of the paddle was set at 50 RPM, while maintaining a temperatu

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Ahammad, Nisar, Nagarjuna Reddy, M. V. Nagabhushanam, and Brahmaiah Ramakrishna. "Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 673–79. http://dx.doi.org/10.22270/jddt.v9i4-s.3334.

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Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic commo

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Raguri, Gopi Chand, Koushik Yetukuri, and Rama Rao Nadendla. "Trend Analysis of Anti-Viral Drugs Approved by USFDA during 2019-2023." International Journal of Pharmaceutical Investigation 14, no. 4 (2024): 1174–80. http://dx.doi.org/10.5530/ijpi.14.4.128.

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Fahmi, A. Suhaeli, Moch Maksum, and Endy Suwondo. "USFDA Import Refusal and Export Competitiveness of Indonesian Crab in US Market." Agriculture and Agricultural Science Procedia 3 (2015): 226–30. http://dx.doi.org/10.1016/j.aaspro.2015.01.044.

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Shaikh, J., and M. Samnaliev. "HPR22 Real-World Evidence Usage in Regulatory Approvals from USFDA and EMA." Value in Health 26, no. 6 (2023): S215. http://dx.doi.org/10.1016/j.jval.2023.03.1169.

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Bhanwra, Sangeeta, Sonia S. Mahajan, and Rajiv Kumar. "Lasmiditan: the first neurally acting anti-migraine drug." International Journal of Basic & Clinical Pharmacology 10, no. 6 (2021): 745. http://dx.doi.org/10.18203/2319-2003.ijbcp20212088.

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Lasmiditan is the first neurally acting drug for the treatment of acute migraine. It is a highly selective, orally acting 5-HT1F agonist that was approved in November 2019, for the acute treatment of migraine in adults, with or without aura, by USFDA. Lesmiditan may help in terminating the acute attack of migraine by inhibiting the central and peripheral neuronal activity and the release of CGRP.

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Mirza, Mohd A., and Zeenat Iqbal. "3D Printing in Pharmaceuticals: Regulatory Perspective." Current Pharmaceutical Design 24, no. 42 (2019): 5081–83. http://dx.doi.org/10.2174/1381612825666181130163027.

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Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engin

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Ghosal, Samit, and Binayak Sinha. "Gliptins and Cardiovascular Outcomes: A Comparative and Critical Analysis after TECOS." Journal of Diabetes Research 2016 (2016): 1–7. http://dx.doi.org/10.1155/2016/1643496.

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The issue related to macrovascular outcomes and intensive glycemic control was hotly debated after the publication of landmark trials like ACCORD, ADVANCE, and VADT. The only benefits seem to come from intervening early on in the disease process as indicated by the 10-year UKPDS follow-up. To complicate matters USFDA made it mandatory for modern drugs to conduct cardiovascular safety trials in high-risk populations after the 2008 rosiglitazone scare. This led to all the modern group of drugs designing cardiovascular safety trials (gliptins, GLP-1 agonists, and SGLT-2 inhibitors) to meet USFDA

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Chawan, Vihang S., Sagar V. Badwane, Kalpesh V. Gawand, Abhishek M. Phatak, and Madhura S. Naik. "Analysis of randomized clinical trials leading to new drug approvals in India and USA." International Journal of Clinical Trials 3, no. 2 (2016): 68. http://dx.doi.org/10.18203/2349-3259.ijct20161413.

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<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>To analyse the number of randomized clinical trials and subsequent new drug approvals in India and USA.</p><p class="abstract"><strong>Methods:</strong> Data was collected for completed randomized clinical trials done by multinational in India and USA from www.clinicaltrials.gov during the period from 1/1/2009 to 31/08/2014 and the subsequent new drug approvals from 1/1/2010 to 31/10/2015 for India obtained from Central Drugs Standard Control Organization (CDSCO) (www

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Sillankorva, Sanna M., Hugo Oliveira, and Joana Azeredo. "Bacteriophages and Their Role in Food Safety." International Journal of Microbiology 2012 (2012): 1–13. http://dx.doi.org/10.1155/2012/863945.

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The interest for natural antimicrobial compounds has increased due to alterations in consumer positions towards the use of chemical preservatives in foodstuff and food processing surfaces. Bacteriophages fit in the class of natural antimicrobial and their effectiveness in controlling bacterial pathogens in agro-food industry has led to the development of different phage products already approved by USFDA and USDA. The majority of these products are to be used in farm animals or animal products such as carcasses, meats and also in agricultural and horticultural products. Treatment with specific

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Raharjo, Tri Joko, Tri Wahyudi, and Sismindari Sismindari. "USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN." Indonesian Journal of Chemistry 10, no. 1 (2010): 138–41. http://dx.doi.org/10.22146/ijc.21494.

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Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugs should show bioequivalence with the originator drug prior to registration. Bioequivalence testing (BE-testing) has to be performed to the people that represented of population to which the drug to be administrated. BE testing need a valid bio-analytical method for certain drug target and group of population. This research report specific validation of bio-analysis of Rifampicin in Indonesian serum specimen in order to be used for BE testing. The extraction was performed using acetonitrile while the chromatog

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Blanchetti-Revelli, Lanfranco. "Keeping Meat and Dairy Consumers Slim: Philippine Seaweed, American Carrageenan and the USFDA." Anthropology Today 13, no. 5 (1997): 6. http://dx.doi.org/10.2307/2783558.

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Parth, Killedar* Tanuja Khopade Siddhi Kurhade Nutan Kokare Shubhangi Khemnar S. D. Mankar. "Comparative Study of Regulatory Requirements for Drug Approval (USFDA vs. EMA vs. INDIA)." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3002–13. https://doi.org/10.5281/zenodo.15276998.

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Before a new drug can be approved for import or manufacturing, it must be proven safe and effective for humans. Every nation has a regulatory body that examines research data to ensure the medication complies with safety and efficacy standards for public health. The regulatory affairs division of a company plays an essential role in guaranteeing adherence to the laws, regulations, and guidelines established by different regulatory authorities in other countries.[1] This article seeks to examine the different facets of the drug authorization procedure in the USA, Europe, and India. Current limi

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More, Ghansham S., Asha B. Thomas, Sohan S. Chitlange, Rabindra K. Nanda, and Rahul L. Gajbhiye. "Nitrogen Mustards as Alkylating Agents: A Review on Chemistry, Mechanism of Action and Current USFDA Status of Drugs." Anti-Cancer Agents in Medicinal Chemistry 19, no. 9 (2019): 1080–102. http://dx.doi.org/10.2174/1871520619666190305141458.

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Background & Objective: :Nitrogen mustard derivatives form one of the major classes of anti-cancer agents in USFDA approved drugs list. These are polyfunctional alkylating agents which are distinguished by a unique mechanism of adduct formation with DNA involving cross-linking between guanine N-7 of one strand of DNA with the other. The generated cross-linking is irreversible and leads to cell apoptosis. Hence it is of great interest to explore this class of anticancer alkylating agents.Methods::An exhaustive list of reviews, research articles, patents, books, patient information leaflets,

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de Sousa, Ana Carolina C., Keletso Maepa, Jill M. Combrinck, and Timothy J. Egan. "Lapatinib, Nilotinib and Lomitapide Inhibit Haemozoin Formation in Malaria Parasites." Molecules 25, no. 7 (2020): 1571. http://dx.doi.org/10.3390/molecules25071571.

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With the continued loss of antimalarials to resistance, drug repositioning may have a role in maximising efficiency and accelerating the discovery of new antimalarial drugs. Bayesian statistics was previously used as a tool to virtually screen USFDA approved drugs for predicted β-haematin (synthetic haemozoin) inhibition and in vitro antimalarial activity. Here, we report the experimental evaluation of nine of the highest ranked drugs, confirming the accuracy of the model by showing an overall 93% hit rate. Lapatinib, nilotinib, and lomitapide showed the best activity for inhibition of β-haema

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Patel, Jimi, Priti Mehta, and Vaishali Kothari. "COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER." International Journal of Drug Regulatory Affairs 3, no. 3 (2018): 8–20. http://dx.doi.org/10.22270/ijdra.v3i3.167.

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To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption

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Pooja Chaudhari and Jitendra Kumar Badjatya. "Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia." International Journal of Drug Regulatory Affairs 7, no. 4 (2019): 40–55. http://dx.doi.org/10.22270/ijdra.v7i4.371.

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This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for th

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Jagatp, Sneha R., and Omprakash G. Bhusnure. "A Review on Eight System Inspection Model." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 713–19. http://dx.doi.org/10.22270/jddt.v9i4.3140.

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The FDA's Drug Manufacturing Inspection Compliance Program, which constitutes instructions to FDA personnel for conducting inspections, is a systems-based approach for inspections and is very consistent with the robust quality systems model presented in this guidance. The diagram below shows the relationship among the six systems: the quality system and the five manufacturing systems. The quality system provides the foundation for the manufacturing systems that are linked and function within it. The quality systems model described in this guidance does not treat the five manufacturing systems

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Shakira, Anam Ilyas, Laiba Anwar, et al. "Computational study on gabapentin as a potential therapy for partial seizures." World Journal of Biology Pharmacy and Health Sciences 12, no. 3 (2022): 025–32. http://dx.doi.org/10.30574/wjbphs.2022.12.3.0204.

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US Food and Drug Administration (USFDA) approved gabapentin as an adjuvant treatment for refractory partial seizures and several diverse disorders. The drug has a relatively safe profile and is well tolerated; however, awareness is required to monitor the patient's medication, its misuse, and how to approach better patient fate. Despite the enormous scientific hypothesis encircling the drug, there is a requisite to research further about the novelty of the drug. The review delineates the drug profile, synthesis, pharmacology, ADME properties, and computational study of gabapentin.

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Shakira, Ilyas Anam, Anwar Laiba, et al. "Computational study on gabapentin as a potential therapy for partial seizures." World Journal of Biology Pharmacy and Health Sciences 12, no. 3 (2022): 025–32. https://doi.org/10.5281/zenodo.7636136.

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US Food and Drug Administration (USFDA) approved gabapentin as an adjuvant treatment for refractory partial seizures and several diverse disorders. The drug has a relatively safe profile and is well tolerated; however, awareness is required to monitor the patient's medication, its misuse, and how to approach better patient fate. Despite the enormous scientific hypothesis encircling the drug, there is a requisite to research further about the novelty of the drug. The review delineates the drug profile, synthesis, pharmacology, ADME properties, and computational study of gabapentin.

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DePaola, Angelo. "A new wave in oyster farming: Making oysters cheaper than chicken." Open Access Government 46, no. 1 (2025): 396–97. https://doi.org/10.56367/oag-046-11899.

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A new wave in oyster farming: Making oysters cheaper than chicken After a 37-year career as Lead Seafood Microbiologist at the USFDA, Dr Angelo DePaola decided to tackle a different challenge: oyster farming. The Shellevator® is poised to change the way oysters are grown. Dr Angelo DePaola’s latest invention presents a sustainable and scalable solution to food production that could revolutionize oyster farming, much like automation transformed chicken farming in the 1950s, making oysters a more affordable and sustainable source of protein.

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Imran, Mohd, Abdulaziz Khalaf Alshammari, Khalid Ramadan Alhamad, et al. "Mavorixafor: A spotlight on the clinical aspects and prospects of the first USFDA-approved treatment for the primary immunodeficiency WHIM syndrome." Advancements in Life Sciences 11, no. 4 (2024): 726. http://dx.doi.org/10.62940/als.v11i4.3504.

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WHIM syndrome (WHIMS) is an extremely rare, severe, and potentially fatal genetic condition that affects the immune system, leading to warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM). Effective therapy for WHIMS requires regular monitoring, medical intervention, and a collaborative approach to treatment. Due to the limited therapeutic options, addressing WHIMS is an unmet medical need. The United States Food and Drug Administration (USFDA) recently granted approval for mavorixafor as the first treatment for WHIMS. This review focuses on the pharmacological characteristics, c

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Chacko, S., S. K Viswam, N. Ravindra Reddy, V. Sharma, and A. Bellapu. "PRS58 MEPOLIZUMAB INDUCED MYALGIA: A DISPROPORTIONALITY ANALYSIS IN USFDA ADVERSE EVENT REPORTING SYSTEM DATABASE." Value in Health 22 (November 2019): S882. http://dx.doi.org/10.1016/j.jval.2019.09.2547.

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