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Generic Sponsors Need To Increase Communications About Drug Master Files, US FDA Says

 
• By Derrick Gingery

Industry complaining about issues in DMF completeness assessments, but few sponsors schedule teleconferences after complete response letters, FDA says.

FDA entrance sign 2016

The US FDA and the generics industry may need to increase awareness efforts so drug master file (DMF) sponsors take full advantage of the available resources to discuss problems with their applications.

Industry representatives complained to FDA officials during a June 29 quarterly meeting on implementation of the generic drug user fee...

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