GMPs

FDA Relaxes Medical Gas GMP Compliance Guidance

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More

Indiana Compounder Indicted on Conspiracy, Drug Potency

Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More