CDER director urges manufacturers to work with FDA to fix inspection issues before shutting down
As policymakers continue to chip away at fixes to ongoing drug shortages, the FDA’s drug center head is urging manufacturers to work with FDA on inspection issues before halting production of critical medications.
During a presentation at the FDA’s joint meeting with the Parenteral Drug Association on Monday, FDA’s CDER Director Patrizia Cavazzoni explained that there is little market incentive for manufacturers to produce excess product, which is particularly an issue for sterile injectables like common cancer drugs. As of Aug. 16, cancer medications were in ongoing shortage, she said.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.