Quality/GMPs

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

Articles

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

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

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.

Biosimilars Poised for Gains in US Market

States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines. 

Drug Production Draws Multiple Contenders

Increased reliance on foreign producers raises concerns and spurs collaborations.

Global Supply Issues Create Challenges

Pressures on FDA will affect industry’s success in bringing new therapies to market.

Regulatory Beat