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Webcast | Virtual

Event Title
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions
November 20, 2020

Date:
November 20, 2020

 

This webinar, and the guidance it accompanies, is 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 on which an applicant relies in seeking 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.

FDA PRESENTER
James Hanratty, JD
Regulatory Counsel
Division of Policy Development (DPD) | Office of Generic Drug Policy (OGDP) | Office of Generic Drugs (OGD) | Center for Drug Evaluation and Research (CDER)

RESOURCES

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