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The Securities and Exchange Commission (SEC) issued a subpoena to Mallinckrodt in August for documents relating to the company’s lawsuit against the Centers for Medicare & Medicaid Services, the company disclosed on Tuesday. Read More
The FDA invited comments on a draft guidance that outlines what the agency considers best practices for postmarket safety surveillance for drugs and biologics. Read More
The FDA has begun the second phase of its CDER reorganization efforts aimed improving drug reviews, including three new offices to handle medicines for cancers, infectious diseases and neurological disorders. Read More
Incomplete cGMP records, active ingredient testing and quality unit shortcomings prompted the FDA to issue a warning letter to Bingbing Pharmaceuticals, an OTC drugmaker in Hubei, China. Read More