FDA Policy/General

FDA to Roll Out ‘Program Alignment’ in May

FDA’s Office of Regulatory Affairs (ORA) plans to implement its long-awaited Program Alignment Group initiative by 5/15. Under the plan, the field force will shift to a commodity-based, vertically integrated inspection program, with specialized inspection cadres for FDA-regulated products and inspection operations. “ORA will maintain 20 district offices across the U.S.; some will concentrate on certain product areas, such as food or drugs, with additional specialists covering other areas,” according to a report published in Applied Clinical Trials.

To roll out the program, ORA now has senior-level program directors at FDA headquarters in Maryland who oversee operations for six main product areas — food, biologics, drugs, medical devices, bioresearch monitoring (BIMO), and tobacco, plus operations involving imports and ORA laboratories. Each district office will have a director and program managers to head inspection cadres at each location, according to a related report. ORA plans to roll out more details and organizational information over the coming weeks.

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