Regulatory

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.

Life sciences companies uniquely tasked with meeting continuous and complex compliance-reporting requirements.

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.

Pharma and life science companies can reduce time to market by optimizing regulatory content management and submission processes.

Assessing the implications for the pharma industry of the America Rescue Plan Act of 2021, which provides nearly two trillion dollars in funding for various government programs, including many related to public health.

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.

Dr. Amy P. Abernethy talks about her career moves from academia to industry to the US Food & Drug Administation.

The European Medicines Agency (EMA) has published a guide to implementing IDMP data standards that will be ”a game changer” for the life sciences sector. Remco Munnik, who has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, provides the inside track on the implications for life sciences companies.

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.

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 pharmaceutical industry must be prepared for the coming wave of COVID-related safety 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.

Examining the current biosimilar market.

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.