Jill Wechsler, Pharm Exec’s Washington Correspondent

A NASEM report for CDER outlines strategies to modernize pharmaceutical manufacturing to ensure reliable access to high-quality drugs, particularly in response to disruptions caused by the pandemic.

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 this week 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.

Pressure on to advance the three separate fee plans.

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

With Sen. Bernie Sanders leading the charge on Capitol Hill, the campaign to limit U.S. outlays for prescription drugs has accelerated.

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.

Efforts made to ensure drug quality, reviews amid pandemic.

Agency faces a significant backlog 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 critical disruptions and added challenges 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.

President Joe Biden has unveiled a lengthy program for combatting COVID-19 by ramping up distribution and inoculation of millions of Americans over the next three months.

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

Administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.

Biden administration faces key decisions on drug testing and access amid vaccine distribution challenges.

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.

Applications put on hold as agency limits alternative oversight methods.

President Trump finally signs the critical year-end COVID-19 package, appropriating $2.3 trillion to finance the federal government through September 2021 and providing critical support for individuals and entities suffering from the economic crisis wrought by the pandemic.

Jill Wechsler reports on FDA's newly published strategies supporting broader eligibility criteria for Phase III studies.

FDA is poised to approve an Emergency Use Authorization (EUA) for the much anticipated vaccine against COVID-19 developed by Pfizer/BioNTech following a strong vote of support by the Agency's vaccine advisory committee