FDA Policy/General

FDA Import Operation Chief Leaves FDA for Law Firm

After a 24-year career, FDA Division of Import Operations director Domenic J. Veneziano has left the agency to join international trade and regulatory law firm Sandler, Travis & Rosenberg as an independent FDA regulatory and strategic consultant. In his new role, Veneziano will provide advice to producers, importers, exporters and distributors of FDA-regulated commodities; evaluate medical device and food facilities to determine compliance with good manufacturing practice regulations; and assist clients in correcting any deviations found during FDA inspections or third-party audits, the law firm says.

As director for the last 10 years, Veneziano was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to about 1,000 field investigators in more than 320 U.S. ports of entry. He was also responsible for ensuring that all FDA and U.S. Customs and Border Protection systems such as PREDICT and ACE met operational needs.

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