View from Washington

Articles

Vaccine manufacturers anticipate significant boosts in output in the coming weeks.

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

FDA issues a sharp warning letter rebuking AcelRx Pharmaceuticals for its ”glib and simplistic” messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

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.

FDA Documents Recent Achievements, Maps Plans for Continued Progress

R&D on medical treatments lags notable success with vaccines.

Where Are the Therapeutics to Combat COVID-19?

The selection of a new FDA commissioner has become a contentious issue in Washington. Jill Wechsler reports.

New Leadership for FDA Entangled in Politics

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. Jill Wechsler reports.

Will Democrats Squeeze Down Drug Prices?

The process of distributing millions of doses of new vaccines across the nation has been much less effective than anticipated.

Vaccine Rollout Worse than Expected, Mars Research and Regulatory Successes

Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.

FDA Struggles to Fend Off Further Attacks from Trump Administration

Applications put on hold as agency limits alternative oversight methods.

FDA Inspection Shutdown Increasingly Delays Approvals

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.