FDA Policy/General

Latest Federal Register Notices

Info Collection Extension for Drug Patent Listings
Federal Register notice: FDA seeks comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements.” 05/17/2019

Fed Reg Correction on Device Accessories
Federal Register notice: FDA corrects a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, which included a finalized list of accessories suitable for Class 1. 05/17/2019

ANDA Product-specific Bioequivalence Guides
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs. 05/15/2019

Guide on Demonstrating Biosimilar Interchangeability
Federal Register notice: FDA makes available a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” 05/14/2019

Regulatory Review Period for Gore’s Viabahn
Federal Register notice: FDA determines the regulatory review period for W.L. Gore & Associates’ Gore Viabahn VBX Balloon Expandable Endoprosthesis. 05/13/2019

Meeting on User Fee Financial Transparency
Federal Register notice: FDA announces a 6/7 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” 05/13/2019

Regulatory Review Period for Austedo
Federal Register notice: FDA determines the regulatory review period for Auspex Pharmaceuticals’s Austedo (deutetrabenazine), indicated for treating chorea associated with Huntington’s disease. 05/13/2019

Guide on Submitting ANDA or 505(b)(2) NDA
Federal Register notice: FDA makes available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 05/10/2019

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