FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.

There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.

Unlike AMAG's Makena, nearly all the products that have seen their accelerated approvals pulled have left the market quietly, our infographic shows.

CBER’s Peter Marks says agency assesses the importance of durability of effect differently for a gene therapy that treats a disease that has no other available therapies versus a condition for which there are multiple approved treatments. Marks’ comments shed more light on the complete response letter for BioMarin’s hemophilia gene therapy Roctavian.

Communication and education on samidorphan’s opioid antagonistic effects should focus on health care providers that prescribe opioids as well as psychiatrists that prescribe olanzapine, advisory committee says in endorsing the safety and efficacy of ALKS 3831.

Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.