Regulatory Beat

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

July 01, 2020

BioPharm International

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

Generic Drugs in Spotlight as Pandemic Creates Shortages

June 01, 2020

BioPharm International

FDA and the US Congress support innovation and access to cheaper medicines.

Modern Drug Manufacturing Key to COVID-19 Response

May 01, 2020

BioPharm International

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

Biosimilars Poised for Gains in US Market

April 01, 2020

BioPharm International

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Drug Production Draws Multiple Contenders

March 01, 2020

BioPharm International

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

Global Supply Issues Create Challenges

February 01, 2020

BioPharm International

Increased reliance on foreign producers raises concerns and spurs collaborations.

Pharma Regulation to be Shaped by Pricing and Production Issues

January 01, 2020

BioPharm International

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

More Consistent Drug Inspection System on Horizon

November 01, 2019

BioPharm International

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

Data Integrity Violations Draw Strong FDA Rebukes

October 01, 2019

BioPharm International

Falsified documents and manipulated test results prompt warnings and investigations.

More Predictable Post-Approval Change Policy on Horizon

September 01, 2019

BioPharm International

Industry and regulators seek global system that reduces regional differences.