Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

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?

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.


Califf will face challenges that include COVID-19, opioids, and user fees.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.