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About 54 results for "gdufa"

US FDA posts draft guidance on correspondence related to GDUFA...

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between industry and agency US FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry, titled Controlled Correspondence Related to Generic Drug Development.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 Pharma, 5 days ago
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1 images for "gdufa"

JD Supra, 3 weeks ago
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 JD Supra3 weeks ago GDUFA fee: 86 generic drug approvals voluntarily withdrawn  Money Control2 months ago Office of Generic Drugs Reorganization  FirstWord Pharma1 month ago Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Prior Approval Supplements Under the Generic Drug User Fee Amendments of...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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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 News4 days ago FDAnews Announces -- Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  A.M. Best1 week ago FDAnews Announces — Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  Red Orbit1 week ago FDAnews Announces Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014  Pharmacy Choice1 week 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 Will Lagging Generic Approval Rates Increase FDA Backlog?  Pharmacy Times1 month 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 Society5 days 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
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