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Generic Manufacturing Reviews Getting Speedier Communication Program

 
• By Derrick Gingery

Office of Pharmaceutical Quality will alert sponsors about minor CMC issues that may be correctable without forcing another review cycle.

The Office of Generic Drugs’ easily correctable deficiencies concept is spreading to other areas of the review and approval system as part of FDA’s ongoing effort to improve communications with generic drug sponsors.

Chemistry, manufacturing and controls reviewers expect to implement what has been termed “real-time communications” with sponsors to allow minor problems to be fixed quicker. It is part of a push...

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More from North America

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