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FDA releases PMA draft guidance as a response to MDUFA III

08/23/12

In order to meet the aggreement of MDUFA III, the FDA agreed to make all efforts to decrease application review time. As a response to this requirement, the FDA has created a draft guidance that would modify PMA application requirements. This new guidance provides recommendations for PMA acceptance and filing criteria so that PMA applications can be approved faster. The FDA hopes that these guidelines will provide more defined criteria for manufacturers so that PMA applications are complete upon first submission. In addition, the FDA will notify the applicant within 15 days of submission if the application is sufficient so that it can be quickly revised if needed.

This draft guidance was released on July 31, 2012 and will be open for public comment for 45 days.

Read the full guidance and make comments.