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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
The FDA and other international regulators and law enforcement agencies have joined forces to crack down on illegal online drug distributors, requesting the suspension of 4,402 websites that sell illegal and potentially counterfeit products to U.S. consumers. Read More