Quality/GMPs

Articles

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

Can Califf Bring Clarity and Enhanced Credibility to FDA?

 Washington Editor, jillwechsler7@gmail.com.

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?

Biosimilars Move to Center Stage

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

FDA User Fees to Rise and Fall as New Fee Agreements Move Forward

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

FDA Prioritizes Vaccine Review and Process Improvements

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production. 

White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.


Pandemic Highlights Need for Advanced Pharma Manufacturing

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

FDA and Industry Move to Renew New Drug User Fee Programs

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

FDA puts applications on hold as the agency limits alternative oversight methods. 


Regulatory Beat