PRWeb Under the Generic Drug User Fee Amendments (GDUFA) of 2012, FDA requires active pharmaceutical ingredient (API) facilities and finished dosage form (FDF) facilities to pay annual generic drug user fees. Registrar Corp reminds industry of the ... Tamar Securities, 1 week ago
US FDA posts draft guidance on correspondence related to GDUFA Amendments - Express Pharma, 3 weeks ago
FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA - JD Supra, 1 month ago
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GDUFA authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on certain generic FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for ...Pharmaceutical & Medical Packaging News, 1 month ago GDUFA fee: 86 generic drug approvals voluntarily withdrawn Money Control, 2 months ago Will Lagging Generic Approval Rates Increase FDA Backlog? Pharmacy Times, 2 months ago
Generic drugmakers: You have until OCT. 1 to be GDUFA-ready. Help is at hand. Read this NOW . For generic drugmakers, Oct. 1 is Crunch Time — the date after which all your ANDA amendment and prior-approval supplement applications must meet ...FDA News, 3 weeks ago FDAnews Announces -- Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014 A.M. Best, 1 month ago FDAnews Announces — Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014 Red Orbit, 1 month ago FDAnews Announces Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014 Pharmacy Choice, 1 month ago
The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened. In a statement yesterdayit praised generics for providing life-saving drugs for ...Pharma Letter, 5 days ago FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA JD Supra, 1 month ago Implementing The Generic Drug User Fee Act: Struggles And Successes AAPS Pharmceutica, 1 month ago Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 49025) - Hearing Pharmacy Choice, 2 weeks ago
) - "Today, more than 50 individuals representing the generic drug industry and more than 20 Generic Pharmaceutical Association (GPhA) member companies stand together to call attention to areas where the Generic Drug User Fee Act (GDUFA) process and ...FirstWord Pharma, 6 days ago GPhA President and CEO Makes Statement Regarding the FDA's Public Hearing on GDUFA Pharmacy Times, 6 days ago
Pharmaceutical export from India continues to be in trouble with the growing global competition and recurrent regulatory actions against some of the top Indian companies. India's total pharmaceutical exports registered slowest growth rate of just 2 ...PharmaBiz, 1 week ago
Participants: Richard J. Holl, Ph.D., Director, Pharmaceutical Science Todd Stutzman, RPh, Director, Pharmaceutics Aileen Ruff, Strategic Director, Advanced Delivery Technologie Min Park, Group Product Manager, Advanced Delivery ...PharmTech.com, 2 weeks ago
Top News DEA Finalizes Hydrocodone Regulations Hydrocodone with acetaminophen has been the , with more than 135 million prescriptions written in 2012. Due to its high potential for abuse, the drug has received much attention in the last several ...Lexology, 3 weeks ago
Posted 02 April 2013 By Zachary Brousseau, senior manager, communications The electronic Common Technical Document (eCTD) is designed to make regulatory submissions easier and more efficient-for ...Regulatory Affairs Professionals Society, 4 weeks ago
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