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A picture of wide manufacturing violations appears in a recently disclosed FDA form 483 report on a site visit to Emergent’s Baltimore vaccine plant.

FDA Inspectors Cited Critical Problems at Emergent Facility

Updated programs supporting the development and review of prescription medicines are being readied for approval by federal agencies and ultimately by Congress

FDA, Industry Move to Finalize New Drug User Fee Programs

New American Jobs Plan set to be funded by corporate taxes will affect biopharma industry.

Biden Infrastructure Package Would Boost R&D–and Corporate Taxes

FDA is reviewing the record of its accelerated approval program following recent withdrawals of certain key indications for several leading cancer therapies, based on the failure of post-approval studies to document extended benefits of treatment.

FDA Reviews Gains, Risks of Accelerated Approval Process

Federal Trade Commission to launch a broad review of drug-company mergers.

FTC Eyes Crackdown on Pharma Mergers

Concerns mount among regulated industry stakeholders as White House stalls on naming FDA permanent commissioner.

Where’s FDA’s Permanent Commissioner?

With the cancellation of most field site visits last year due to the coronovirus pandemic, FDA now faces a serous backlog in inspections both in the US and abroad.

Pressure Mounts for FDA to Ramp Up Drug Inspections

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.