viernes, 11 de julio de 2014

CDER SBIA update - FDA posts draft guidances describing GDUFA performance metrics and associated webinars

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President of the United States of America.  GDUFA was designed to speed the delivery of safe, effective, and high-quality generic drugs to the public.  This program will bring greater predictability and timeliness to the review of generic drug applications. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry.
On July 10, FDA published two notices in the Federal Register announcing the availability of:
  • Draft Guidance for Industry ANDA Submissions – Prior Approval Supplements Under GDUFA
  • Draft Guidance for Industry: ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA 
These draft guidances are intended to assist applicants preparing to submit amendments to ANDAs, prior approval supplements, and amendments to prior approval supplements under the Federal Food, Drug, and Cosmetic Act, by explaining how the GDUFA performance metrics apply to these submissions.
CDER SBIA is announcing the availability of its accompanying pre-recorded webinars, slides and documents:
CDER SBIA archived webinars – click here

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey:

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