Regulatory Watch

FDA and Industry Prepare for Transition from Emergency Use Authorizations

May 02, 2022

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

FDA Maps Strategies to Advance Pharmaceutical Quality

April 02, 2022

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

A Rocky Road Ahead for Commissioner Califf

March 02, 2022

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

Global Vaccine Access Challenges FDA and Industry

February 02, 2022

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

Major Challenges Ahead for FDA and Pharma

January 02, 2022

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

FDA Grapples with the Promise and Perils of Gene Therapy

December 03, 2021

High price tags threaten to block patient access to potentially life-saving cures and treatments.

Pandemic Alters Policies and Practices for Drug Development and Regulation

December 02, 2021

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

Pandemic Alters FDA Inspections and Quality Oversight

November 02, 2021

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

October 15, 2021

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

FDA Moves to Advance Innovative Excipients

October 02, 2021

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.