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