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Industry Faces Sept. 15 Deadline in FDA Enforcement Crackdown

August 10, 2009

Industry Faces Sept. 15 Deadline in FDA Enforcement Crackdown
The FDA has set a Sept. 15 start date for drug and biologic manufacturers after which they accept 15 working days to respond to weighty Form 483 observations, taken in the character of determined through the agency. FDA Commissioner Margaret Hamburg unveiled the revamped enforcement policies in a language last week. The FDA began streamlining the warning letter review process Aug. 6, Assistant Commissioner on this account that Policy David Horowitz said.

Written by Samanta · Filed Under Uncategorized