Quality Systems

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

Articles

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

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

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

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

FDA is encouraging alternative insulins and challenging anticompetitive practices.

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

Increased reliance on foreign producers raises concerns and spurs collaborations.

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

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.  


FDA readies more efficient oversight processes while advancing collaboration with Europe.

Falsified documents and manipulated test results prompt warnings and investigations.