Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

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

FDA and Industry Prepare for Transition from Emergency Use Authorizations

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


FDA Maps Strategies to Advance Pharmaceutical Quality

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

A Rocky Road Ahead for Commissioner Califf 

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

Global Vaccine Access Challenges FDA and Industry

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

Major Challenges Ahead for FDA and Pharma

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

Pandemic Alters Policies and Practices for Drug Development and Regulation

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

Pandemic Alters FDA Inspections and Quality Oversight

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

Can Califf Bring Clarity and Enhanced Credibility to FDA?

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.

FDA Moves to Advance Innovative Excipients

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

Regulatory Beat