FDA to accelerate review of Pfizer Covid vaccine, STAT reports

The Food and Drug Administration is planning to deprioritize some of its existing work in an effort to accelerate its review of Pfizer's application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT, reports Nicholas Florko. The process requires FDA staff to review millions of pages of data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDA's approved label and the company's post-marketing responsibilities, notes Florko. A senior FDA official told STAT that the agency will initiate a "sprint." Under a new plan, the director of FDA's biologics center, Peter Marks, will largely oversee review of the Pfizer application, a second FDA source told the website. Reference Link