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The U.S. Government Accountability Office faulted the FDA’s approach to regulatory science and its strategic management plan in two reports the agency issued Wednesday critical of the agency. Read More
A former FDA official has been hit with insider-trading charges by the Securities and Exchange Commission for supposedly sending confidential information about FDA approvals to a hedge fund manager. Read More
British authorities are ordering a U.S. manufacturer to recall drug batches, suspend clinical trials and cease distribution after an inspection uncovered critical GMP violations. Read More
The FDA is allowing certain biologic products to carry stand-alone symbols on labels, in an effort to harmonize requirements with EU standards. Read More