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In this section: General Biologics Guidances

Generics Guidances

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Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Guidance for Industry
CDER/CBER, January 2022
ANDA Submissions - Content and Format of Abbreviated New Drug Applications
CDER/CBER, September 2018
ANDA Submissions - Prior Approval Supplements Under GDUFA
CDER/CBER, October 2017
Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)
CDER/CBER/ORA, November 2016
Self-Identification of Generic Drug Facilities, Sites, and Organizations
CDER/CBER, September 2016

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