Drugs

Draft Pediatric Oncology Studies Guidance

FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and BLAs are expected to be submitted to FDA on or after 8/18/20 in accordance with provisions of Section 505B of the Federal Food, Drug, and Cosmetic Act. The document notes that Section 505B, also known as the Pediatric Research Equity Act, was amended by the FDA Reauthorization Act (FDARA).

“The amendments provide a new mechanism to expedite the evaluation of certain novel drugs with the potential to address an unmet medical need of pediatric patients with cancer,” the guidance says. “Specifically, FDARA amended the requirement for pediatric investigations of certain new targeted cancer drugs to be based on molecular mechanism of action rather than clinical indication.”

The draft provides recommendations on regulatory considerations related to the amendments to Section 505B, including information on molecular targets, factors the agency intends to consider in determining whether a molecular target is substantially relevant to the growth or progression of a pediatric cancer, the molecular target lists, content of the initial pediatric study plan and description of recommended studies, additional considerations for rare cancers, and consideration for planned waivers and deferrals. It also has information on global implications and international collaboration.

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