Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions

Image of SBIA Webinar 2016

 

Webinar Now Available

 

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

CDER is making available the pre-recorded webinar "Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions". This webinar, and the guidance it accompanies, are intended to help applicants submitting an abbreviated new drug application (ANDA) seeking approval of a generic drug to identify:

  • A reference listed drug (RLD), i.e., a previously approved drug product for which an applicant seeks approval of a generic drug;
  • a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in conducting any in vivo bioequivalence testing required to support approval of its ANDA; and
  • the basis of submission for the ANDA.

 

Speaker:

Gail Schmerfeld, J.D.
Policy Advisor
Division of Policy Development
Office of Generic Drug Policy | Office of Generic Drugs
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
 

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

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