FDA Policy/General

Latest Federal Register Notices

Draft Guide on Blood Glucose Monitoring 510(k)s
Federal Register notice: FDA makes available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” 11/30/2018

Draft Guide on OTC Blood Glucose Monitors
Federal Register notice: FDA makes available a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” 11/30/2018

Panel to Review Amgen Osteoporosis Therapy BLA
Federal Register notice: FDA announces a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting to discuss an Amgen BLA for osteoporosis therapy romosozumab injection. 11/30/2018

Joint Panels to Review Uloric Cardiovascular Safety
Federal Register notice: FDA announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting to review Takeda drug Uloric’s cardiovascular safety. 11/29/2018

FDA Updates ANDA Product-specific Guides
Federal Register notice: FDA issues 22 new and 41 revised ANDA product-specific guidances. 11/29/2018

Draft Guide on Dual 510(k) and CLIA Waiver
Federal Register notice: FDA makes available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” 11/29/2018

Panel to Review Sanofi Diabetes Drug
Federal Register notice: FDA announces a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Sanofi-Aventis NDA for diabetes drug sotagliflozin. 11/29/2018

Draft Guide on CLIA Recommendations
Federal Register notice: FDA makes available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” 11/29/2018

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