Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

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. 


FDA Inspection Shutdown Increasingly Delays Approvals

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.

Pandemic Control to Shape Biopharma in 2021

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies. 



Pandemic Brings Major Changes to FDA and Drug Development in 2020

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

Trump’s Revenge on Pharma

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

Surge in Cellular and Gene Therapies Challenges FDA

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients. 

FDA Caught in Political Crossfire

FDA can better monitor quality production of domestic versus foreign firms. 

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

FDA and the US Congress support innovation and access to cheaper medicines. 

Regulatory Beat