miércoles, 22 de abril de 2015

CDER SBIA Update: Generic Copaxone and GDUFA public meeting

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

Generic Copaxone and GDUFA public meeting

1. FDA approves first generic Copaxone to treat multiple sclerosis
FDA has approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection.
The FDA applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.
For more information please visit: glatiramer
2. Generic Drug User Fees; Public Meeting; Request for Comments
FDA is announcing a public meeting on the Generic Drug User Fee Amendments of 2012 (GDUFA). The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization; we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the Generic Drug User Fee Act Program Performance Goals and Procedures (i.e., the Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's Web site. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program.
The public meeting will be held on June 15, 2015, from 9 a.m. to 5 p.m.

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.

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