FDA Policy/General

Lt. Governors Urge Trump to Support FDA, Other Agencies

The Democratic Lieutenant Governors Association has written president Donald Trump urging him to support and safeguard the integrity of key federal science agencies like FDA, NIH and the CDC, among others, and asked that he promote evidence-based policymaking that strengthens public trust and protects America’s health and prosperity. “The continued success of our country — its economy, security, and global leadership — depends on the strength of our scientific institutions and our ability to nurture talent through education,” the group says in its 4/22 letter.

The letter says the health agencies “fuel American innovation — supporting biomedical research, clean energy development, climate science, technology, and space exploration. They also protect our communities, whether by combating infectious diseases, reviewing life-saving medical treatments, or delivering scientific breakthroughs that create jobs and transform industries.”

The letter concludes by saying that science is a “unifying force — offering solutions that benefit all Americans, regardless of political affiliation,” and it will foster innovation, and build a healthier, more secure future for Americans.

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

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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