Quality/GMPs

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

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. 

Generic Drugs in Spotlight as Pandemic Creates Shortages

Policy makers seek to ensure supplies of new therapies and to limit shortages.

Modern Drug Manufacturing Key to COVID-19 Response

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Regulatory Beat