FDA reviewers' requests for more premarket data must be clearly explained, Burlington says.
This article was originally published in The Gray Sheet
FDA DEVICE REVIEWERS' REASONS FOR ADDITIONAL PREMARKET DATA REQUESTS should be clearly explained to sponsors of premarket submissions, Bruce Burlington, director of FDA's Center for Devices and Radiological Health, says in a recent memo to premarket review staff. The device center must not only "clearly understand why we want more data and what it is we want," Burlington says, but must also "clearly and explicitly convey" to the sponsor "what we are looking for and why we want it."
You may also be interested in...
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.
Sanofi R&D head John Reed says the company has kept 95% of patients on its nearly 400 clinical trials, started 59 studies, and benefited from its in-house drug supply management.