OR WAIT null SECS
June 01, 2021
Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
May 01, 2021
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
March 01, 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.
February 01, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
January 01, 2021
The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.
December 01, 2020
Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
November 23, 2020
The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.
October 01, 2020
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
September 01, 2020
Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.
August 24, 2020
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.