Biologics

HCT/P Deviation Reporting Guidance Out

FDA has published a guidance, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, with recommendations and relevant examples for establishments that manufacture certain non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/P) to investigate and report HCT/P deviations. The document says the examples it contains were chosen to illustrate those HCT/P deviations that have been most frequently reported to CBER.

The guidance does not apply to reproductive HCT/Ps nor to HCT/Ps regulated under 21 CFR Part 1270 and recovered before 5/25/05. It also does not apply to healthcare professionals who implant, transplant, infuse, or transfer HCT/Ps into recipients. And it does not apply to HCT/Ps that are regulated as drugs, medical devices, and/or biological products under Section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an IND or IDE.

The guidance finalizes a 12/2015 draft.

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