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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
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
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
A string of proposed rules has been sitting on the FDA’s agenda for lengthy periods of time, sometimes for over a decade, and a recent accounting shows no signs of improvement. Read More