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

The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More

Beacon Prescriptions, a compounding pharmacy in Southington, Conn., was warned by the FDA for unsanitary conditions and other federal violations, according to a letter sent earlier this month. Read More

The FDA has warned a Texas pharmacy for numerous violations, including compounding unapproved drugs and unsanitary conditions. Read More

A Utah supplement company drew a warning from the FDA for failing to comply with GMP requirements. Read More

An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More