FDA Policy/General

Latest Federal Register Notices

Draft Guide on Rare Diseases with Substrate Deposition
Federal Register notice: FDA makes available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” 07/27/2018

Guide on Certain Pediatric Orphan Designations
Federal Register notice: FDA makes available a final guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” 07/27/2018

FY 2019 Generic Drug User Fees Set
Federal Register notice: FDA announces the fiscal year 2019 rates for generic drug program areas. 07/27/2018

Guide on Peripheral Vascular Atherectomy Devices
Federal Register notice: FDA releases a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification [510(k)] Submissions.” 07/27/2018

Metaxalone not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that metaxalone tablets, 640 mg were not withdrawn from sale for reasons of safety or effectiveness. 07/27/2018

Info Collection Extension for Product Interruption Notices
Federal Register notice: FDA submits to OMB an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products — 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82.” 07/26/2018

Guide on Certain Drug Quality Assessments
Federal Register notice: FDA makes available a draft guidance entitled “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.” 07/25/2018

FDA Hearing on Improving Biosimilar Marketplace
Federal Register notice: FDA announces a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketplace. 07/25/2018

Pharmacy Compounding Advisory Committee Meeting 9/12
Federal Register notice: FDA announces a 9/12 Pharmacy Compounding Advisory Committee meeting. 07/24/2018

Workshop on Otic and Vestibular Toxicity
Federal Register notice: FDA announces an 8/21 public workshop entitled “Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.” 07/24/2018

Draft Guide on Inborn Errors of Metabolism
Federal Register notice: FDA makes available a draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” 07/24/2018

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