Drugs

Former FDA Head Kessler Co-chairs Biden Covid Advisors

President-elect Joe Biden’s transition team has announced the formation of the Transition Covid-19 Advisory Board, which is co-chaired by former FDA commissioner David Kessler. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations,” Biden said in a statement. Other notable board members include for acting FDA chief scientist and current vice president at In-Q-Tel Luciana Borio, and whistleblower (see story) and former Biomedical Advanced Research and Development Authority director Rick Bright.

Meanwhile, Biden has issued his plan for combating Covid-19. The plan aims to ensure all Americans have access to regular, reliable, and free testing. He also says the Defense Production Act will be used to ramp up production of masks, face shields, and other protective equipment so that stockpiles are fully replenished. He says his administration will also provide clear, evidence-based guidance for how communities should navigate the pandemic, and resources for schools, small businesses, and families to help them get through the pandemic.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome