The trade association says it is impractical for a sponsor or REMS administrator to conduct a ‘failure modes and effects analysis’ to plan for system failures while United BioSource and the National Council for Prescription Drug Programs supports the testing.

The trade association says it is impractical for a sponsor or REMS administrator to conduct a ‘failure modes and effects analysis’ to plan for system failures while United BioSource and the National Council for Prescription Drug Programs supports the testing.

While FDA commissioner meets with firms on shortages, senators challenge alternative source of platinum chemotherapies, FDA hinges imports from Sun plant on successful media fill runs, Safe Chain warned on Biktarvy suppliers, and the FDA asks Ipca more questions while setting “Mr. Ye” straight.

Surveillance inspections nearly tripled as drug recalls reached highest level in five years, finds agency’s FY 2022 “state of pharmaceutical quality” report. Meanwhile, analysis points to lack of domestic API sources for many essential medicines.