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
FDAnews Announces -- Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014 - A.M. Best, 6 days ago
FDAnews Announces — Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations Webinar, Sept. 23, 2014 - Red Orbit, 5 days ago
1 images for "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between industry and agency US FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry, titled Controlled Correspondence Related to Generic Drug Development.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, 1 day ago FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA JD Supra, 1 week ago Implementing The Generic Drug User Fee Act: Struggles And Successes AAPS Pharmceutica, 1 week ago Changes and Challenges for Generic Drugs PharmTech.com, 2 weeks ago
More from: Lexology, Lexology...and 2 other sources
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 In July 2014, the U.S. Food and Drug ...JD Supra, 3 weeks ago GDUFA fee: 86 generic drug approvals voluntarily withdrawn Money Control, 2 months ago Office of Generic Drugs Reorganization FirstWord Pharma, 1 month ago Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Prior Approval Supplements Under the Generic Drug User Fee Amendments of...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 News, 1 month ago
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, 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, 1 day ago
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 Administration, 1 month ago
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.com, 2 months ago
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, ...BioSpace, 2 months ago
on your WebpageAdd Widget >Get your members hooked!