Home » CDRH: Compliance Approach May Need More Flexibility
CDRH: Compliance Approach May Need More Flexibility
The FDA is considering a more flexible interpretation of its quality system regulations to help devicemakers more effectively respond to post-inspection Form 483s and reverse a nearly decade-long trend of little improvement in enforcement actions, CDRH Office of Compliance Director Steve Silverman said at MedCon 2013.
The GMP Letter
The GMP Letter
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