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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.

Pharma Prices & Patents Under Attack

Sponsors ignoring FDA requirements will now face stricter penalties.

FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results

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

Biden Seeks Added Funding for Medical Research, Disease Tracking

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.

FDA Unveils Extensive Manufacturing Violations at Emergent

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 Shuts Down Emergent Vaccine Facility

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 Lifts Restrictions on Access to Abortion Pill

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.

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

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.