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FDA To Use New Discipline Review Letters In Communicating ANDA Deficiencies To Generic Drugmakers

 
• By Joanne S. Eglovitch

FDA will be issuing discipline review letters and information request letters to generic drug applicants to communicate shortcomings in ANDAs. Under GDUFA II, the US agency agreed to send out these letters at the mid-point of the review clock.

FDA entrance sign 2016

FDA Dec. 15 issued draft guidance explaining its procedures for issuing discipline review letters (DRLs) to communicate deficiencies found in abbreviated new drug applications as well as information request (IR) letters where information is lacking.

FDA agreed under the Generic Drug User Fee Amendments of 2017 to sending out these letters midway through the first...

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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
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