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The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More