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About 85 results for "gdufa"

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA
JD Supra

FDA Generic Drug Facility Fees Due October 1, 2014

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
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1 images for "gdufa"

JD Supra, 1 month ago

FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates

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 Pharmaceutical & Medical Packaging News1 month ago GDUFA fee: 86 generic drug approvals voluntarily withdrawn  Money Control2 months ago Will Lagging Generic Approval Rates Increase FDA Backlog?  Pharmacy Times2 months ago

Impact of GDUFA Performance Metrics on ANDA Approval Times

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 News3 weeks ago FDAnews Announces -- Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  A.M. Best1 month ago FDAnews Announces — Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  Red Orbit1 month ago FDAnews Announces Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  Pharmacy Choice1 month ago
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GPhA calls for feedback and dialogue on US generic legislation

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 Letter5 days ago FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA  JD Supra1 month ago Implementing The Generic Drug User Fee Act: Struggles And Successes  AAPS Pharmceutica1 month ago Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 49025) - Hearing  Pharmacy Choice2 weeks ago
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Statement from Ralph G. Neas, President and CEO, GPhA, Regarding the FDA's Public Hearing on GDUFA

) - "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 Pharma6 days ago GPhA President and CEO Makes Statement Regarding the FDA's Public Hearing on GDUFA  Pharmacy Times6 days ago

TROUBLE WORSENING FOR EXPORTERS

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 ...
 PharmaBiz1 week ago

Outsourcing Perspectives from Catalent Pharma Solutions

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.com2 weeks ago

Pharmaceutical & medical device regulatory update, issue 13

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 ...
 Lexology3 weeks ago
Regulatory Affairs Professionals Society

Mastering the eCTD Format Critical for Regulatory Submissions Pros

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 Society4 weeks ago
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