Regulatory Watch

Pandemic Highlights Need for Advanced Pharma Manufacturing

June 02, 2021

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

FDA and Industry Move to Renew New Drug User Fee Programs

May 02, 2021

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

FDA Documents Achievements and Plans for Future

March 02, 2021

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Inspection Shutdown Increasingly Delays Approvals

February 02, 2021

FDA puts applications on hold as the agency limits alternative oversight methods.

Pandemic Control to Shape Biopharma in 2021

January 02, 2021

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.

Pandemic Brings Major Changes to FDA and Drug Development in 2020

December 02, 2020

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

October 02, 2020

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Surge in Cellular and Gene Therapies Challenges FDA

September 02, 2020

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

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

July 01, 2020

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

Modern Drug Manufacturing Key to COVID-19 Response

May 02, 2020

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