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May 02, 2021
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
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.
February 02, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
January 02, 2021
The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.
December 02, 2020
Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
October 02, 2020
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
September 02, 2020
Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.
July 01, 2020
FDA can better monitor quality production of domestic versus foreign firms.
May 02, 2020
Policy makers seek to ensure supplies of new therapies and to limit shortages.
April 02, 2020
FDA is encouraging alternative insulins and challenging anticompetitive practices.