Regulatory Watch

March 02, 2023

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

February 02, 2023

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

January 02, 2023

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

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.