2007 Healthcare Individual Manufacturing 
FDA Law
AUGUST 21, 2023
FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. A recent state law failure-to-warn case in the SDNY makes that very point.
FDA Law
MAY 26, 2025
The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. 118, 129 (2007) (quoting Abbott Labs v. Such a message may understandably deter the targeted conduct to avoid such a risk. MedImmune, Inc.
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