Columns | View from Washington

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

FDA has responded to pressures for quick and reliable processes with multiple guidance documents and policy initiatives for updating the clinical research process.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.

Sponsors ignoring FDA requirements will now face stricter penalties.

White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.

FDA officials have taken the unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility.

Just two weeks after instructing Johnson & Johnson to take over operations at Emergent BioSolution’s noncompliant Baltimore manufacturing operation, FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

FDA is halting enforcement of a policy that limits prescribing and dispensing of Mifeprex (mifepristone), a widely used drug to induce a medical abortion in the very early stages of pregnancy.

FDA acting commissioner Janet Woodcock announced that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since last spring.

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.

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

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

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.

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

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

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

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

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.

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

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

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

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

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

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.