Regulatory Watch

October 02, 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 02, 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 02, 2022

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

May 02, 2022

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

April 02, 2022

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

March 02, 2022

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

February 02, 2022

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

January 02, 2022

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.