Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

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. 


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.

Regulatory Beat