Drugs

New Genetic Metabolic Disease Treatment A/C

FDA says it is creating a new Genetic Metabolic Diseases Advisory Committee to give the agency independent knowledgeable advice and recommendations on technical, scientific, and policy issues around medical products for genetic metabolic diseases. An agency statement says committee members “will evaluate evidence on key issues about the applications brought before the advisory committee and offer their recommendations for FDA consideration.” The committee is to contain “experts in the areas of metabolic genetics, management of inborn errors of metabolism, small population trial design, translational science, pediatrics, epidemiology or statistics, and related specialties.”

The committee will advise on products used for the diagnosis, prevention, or treatment of genetic metabolic diseases under the purview of the Division of Rare Diseases and Medical Genetics in CDER’s Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine.

It will have nine voting members, including the chairperson, FDA says. Individuals nominated as scientific members must be technically qualified experts in their relevant fields and have experience interpreting complex data. There will be a consumer representative and an industry representative. Members will be invited to serve for overlapping terms of up to four years.

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