We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a five-year strategic plan for 2021-2025 that outlines in broad terms how the center will use advances in science and technology — including increased use of real-world data (RWD) in clinical trials — to help achieve four main goals. Read More
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More
The Senate confirmed Xavier Becerra as HHS secretary yesterday in a narrow 50-49 vote, with just one Republican siding with Democrats to support his confirmation and the closest vote so far for any of President Biden’s Cabinet nominations. Read More
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report. Read More
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Read More
In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House press briefing yesterday. Read More
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More