FDA Releasing Information Related to New Fees Required of Human Generic Drug Manufacturers‏

As of October 1, 2012, all firms that manufacture human generic drugs will need to pay user fees to FDA. User fees are fees paid by industry to FDA to help FDA review manufacturers’ products in a timely manner. FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.

For more information, please visit: GDUFA documents

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Contact Precautions May Have Unintended Consequences

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