Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

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.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA will use virtual site visits even after resuming active inspections.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?