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November 01, 2022
FDA keeps its user fees but fails to gain important reforms.
October 01, 2022
FDA backs joint reviews, common research policies, and modern production methods around the world.
September 09, 2022
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
August 01, 2022
FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
July 18, 2022
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
July 01, 2022
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
June 01, 2022
FDA will use virtual site visits even after resuming active inspections.
May 01, 2022
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
April 01, 2022
Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.
March 01, 2022
Califf will face challenges that include COVID-19, opioids, and user fees.