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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

Pharma Prices and Patents Under Attack

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

Biden Seeks Added Funding for Medical Research and Disease Tracking

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA Unveils Extensive Manufacturing Violations at Emergent

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 Lifts Restrictions on Access to Abortion Pill

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities. 

Pressure Mounts for FDA to Ramp Up Drug Inspections

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production, in expanded emergency production capacity and enhanced US infrastructure for biopreparedness, and in greater production onshore of APIs.   

Biden Infrastructure Package Would Boost R&D and Corporate Taxes

The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices. 

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