US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
Executive Summary
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.
You may also be interested in...
How Will Pfizer Plant’s Tornado Damage Impact Congress’s Drug Shortages Debate?
The stakes on Capitol Hill rose another notch as tornado hit supplies of sterile injectable drugs at North Carolina plant. Workers escaped serious injury by gathering in designated shelters; patients may need effective legislation to escape serious injury from drug shortages.
The Quality Lowdown: As Washington Churns On Drug Shortages, Supply Chain Challenges Grow
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.
US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures
As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.