Drugs

Latest Federal Register Notices

Vertex Gains Priority Review Voucher
Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. 03/29/2019

Proposed Rule Seeks Improved Mammography Services
Federal Register proposed rule: FDA proposes to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act to modernize the regulations by incorporating current science and mammography best practices. 03/28/2019

Cell-Tissue Gene Therapy Committee Renewal
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years. 03/28/2019

Guide on Pediatric Info in Drug/Biologic Labeling
Federal Register notice: FDA makes available a final guidance entitled “Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.” 03/28/2019

Public Meeting on ICH Activities
Federal Register notice: FDA announces a 4/29 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.” 03/27/2019

Reagan-Udall Annual Meeting 5/2
Federal Register notice: FDA announces a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA. 03/27/2019

Info Collection Extension for CLIA Waiver Apps
Federal Register notice: FDA seeks comments on an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) of 1988 waiver applications.” 03/26/2019

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