FDA Policy/General

FDA Removes Obsolete References in Biological Reclassification Rule

Federal Register Final rule: FDA is amending its regulations by removing certain ones that include obsolete references. In the 2/12 Federal Register (81 FR 7445), FDA published a final rule entitled “Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972.” FDA, in part, removed Sec. 601.25 (21 CFR 601.25), which prescribed procedures for FDA’s review of biological products licensed before 7/1/72. Under Sec. 14.1(a)(2) specific provisions are provided for a matter that is subject to a hearing before an advisory committee. In the 2/2016 final rule, FDA inadvertently did not remove these sections (Sec. Sec. 14.1(a)(2)(v) and 20.100(c)(22)) that referenced Sec. 601.25. To view this final rule, 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