Drugs

Trump Signing Order to Relocate Drug Manufacturing to U.S.

The White House says President Trump is signing 8/6 an Executive Order to increase American production of essential medical supplies and cut down U.S. reliance on foreign drug producers. Under the order, FDA is directed to create a list of drugs, medical countermeasures, and “critical inputs” that are essential for public health in America, according to a White House fact sheet. “To support the production of advanced pharmaceutical ingredients and essential medicines in America, the order also directs agencies to prioritize permitting and approvals for domestic manufacturers,” it says.

The White House says that America’s supply chains must be “capable of meeting national security requirements for responding to public health emergencies and other threats... By relocating medical supply chains back home, president Trump is ending this foreign reliance and ensuring that our nation has the resources necessary to respond to public health emergencies and security threats.”

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