FDA Policy/General

Federal Register Notices 7/3 to 7/10

Here the health product-related Federal Register notices published by the agency during FDA Webview’s 7/3-10 annual break for Independence Day:

July 10

Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products — 21 CFR Part 1271.” The collection supports the agency’s regulations covering such product requirements for registering and listing. To view the notice, click here.

Federal Register notice: FDA has announced an 8/1 Medical Imaging Drugs Advisory Committee meeting. Panel members are scheduled to discuss dosimetry data needed to support the initial clinical study in an original IND application for certain new positron emission tomography drugs. To view the notice, click here.

July 3

Federal Register notice: FDA has announced a 9/13 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Alnylam Pharmaceuticals supplemental NDA for Onpattro (patisiran) lipid complex for injection for the proposed treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults. To view the notice, click here.

[Editor’s note: There were no FDA-published Federal Register notices on 7/4, 7/5, 7/6 and 7/7.]

Gupta Raises Concerns About Overton’s Independence, Ideology

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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

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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