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About 112 results for "gdufa"

Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time
FDA News

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 News, 15 hours ago
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1 images for "gdufa"

JD Supra, 3 weeks ago

US FDA posts draft guidance on correspondence related to GDUFA Amendments

Outlines communication process between industry and agency US FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry, titled Controlled Correspondence Related to Generic Drug Development. ...
 Express Pharma1 day ago FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA  JD Supra1 week ago Implementing The Generic Drug User Fee Act: Struggles And Successes  AAPS Pharmceutica1 week ago Changes and Challenges for Generic Drugs  PharmTech.com2 weeks ago
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JD Supra

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

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S. Food and Drug ...
 JD Supra3 weeks ago GDUFA fee: 86 generic drug approvals voluntarily withdrawn  Money Control2 months ago Office of Generic Drugs Reorganization  FirstWord Pharma1 month ago Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Prior Approval Supplements Under the Generic Drug User Fee Amendments of...  Pharmaceutical & Medical Packaging News1 month ago
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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 News3 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 Society1 day ago

eSubmitter Enhancements and Fixes for Version 2.08.01

Provided below is a listing of recent updates to the application software in reverse chronological order by version number. For updates prior to this list, consult the Application History Archive . Version 2.08.01 - Released July 7, 2014 ...
 U.S. Food and Drug Administration1 month ago

US pharma companies want dialogue with India on IPRs

T Arguing that global pharma companies share the same goal of "patient first" with that of the Government of India, corporate executives attending the day-long "US-India BioPharma and Healthcare Summit" organised by the USA-India Chamber of ...
 Moneycontrol.com2 months ago
BioSpace

Selecting the Right Business Partner in Today's Generics Climate

Interview With Richard DiCicco, Chairman With Harvest Moon Pharmaceuticals, on Key Topics to Be Discussed at the Upcoming marcus evans 7th Product & Pipeline Enhancement for Generics Conference, on July 30-31 at the Hilton Alexandria Old Town, ...
 BioSpace2 months ago
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