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March 01, 2021
Vaccine manufacturers anticipate significant boosts in output in the coming weeks.
February 19, 2021
FDA issues a sharp warning letter rebuking AcelRx Pharmaceuticals for its ”glib and simplistic” messaging on painkiller Dsuvia.
February 15, 2021
Despite challenges and disruptions posed by the coronavirus pandemic this past year, FDA annual reports on drug regulatory programs and policies confirm successful efforts for meeting review time frames and updating policies and programs.
February 12, 2021
R&D on medical treatments lags notable success with vaccines.
February 10, 2021
The selection of a new FDA commissioner has become a contentious issue in Washington. Jill Wechsler reports.
February 01, 2021
With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. Jill Wechsler reports.
January 19, 2021
The process of distributing millions of doses of new vaccines across the nation has been much less effective than anticipated.
January 14, 2021
Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.
January 07, 2021
Applications put on hold as agency limits alternative oversight methods.
CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.