Regulatory Watch

April 02, 2020

FDA is encouraging alternative insulins and challenging anticompetitive practices.

March 02, 2020

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

February 02, 2020

Increased reliance on foreign producers raises concerns and spurs collaborations.

January 02, 2020

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

December 02, 2019

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

November 02, 2019

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

October 02, 2019

Falsified documents and manipulated test results prompt warnings and investigations.

August 02, 2019

New tools and policies aim to support more complex manufacturing processes.

July 02, 2019

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.