FDA Policy/General

FDA Reorganizes Headquarters Organizations and Product Centers

Federal Register notice: FDA has announced it has modified organizational structures in the Office of the Commissioner, headquarters organizations, and product Centers. The Office of the Commissioner reorganization will transition the agency away from the directorate structure to realign many functions to the Centers/Office of Regulatory Affairs (ORA). It also establishes a direct communication line between the Centers/ORA and the commissioner. The direct report relationship with the Centers streamlines communications and better positions FDA to support its regulatory programs and mission. The intent is to create a more effective structure that better reflects FDA’s priorities and streamlines operations. The CDRH reorganization will more accurately reflect the functions performed by the Center and help to enhance CDRH’s ability to advance FDA’s mission and streamline operations and support functions. The CDER reorganization changes the organizational structures and revises the functional statements of certain offices. To view the notice, click here.

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