Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

FDA has spurred investment to create and develop 600 therapies.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers. 

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

Health crises, political tension, and budget concerns were major challenges.

FDA keeps its user fees but fails to gain important reforms.

FDA backs joint reviews, common research policies, and modern production methods around the world.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.