FDA Policy/General

Latest Federal Register Notices

Guide on Generic Abuse-deterrent Opioids
Federal Register notice: FDA makes available a guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” 11/22/2017

Panel to Review Clarus Therapeutics Testosterone Replacement
Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville, MD that will review testosterone replacement NDA. 11/22/2017

10th Annual Sentinel Public Workshop
Federal Register notice: FDA announces a 2/7-8/2018 public workshop entitled “Tenth Annual Sentinel Initiative Public Workshop.” 11/22/2017

Comments Sought on Info Collection Under 513(g) Devices
Federal Register notice: FDA seeks comments on an information collection extension for “513(g) Request for Information OMB Control Number 0910-0705.” 11/21/2017

Comments Sought on Device Accredited Person Inspections
Federal Register notice: FDA seeks comments on an information collection extension for its guidance on “Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program OMB Control Number 0910-0569.” 11/21/2017

Comments Extended on Cardiac Troponin Assays
Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments.” 11/20/2017

Comments Sought on Petition for OTC Denture Repair Kits
Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements for over-the-counter denture repair kits. 11/20/2017

Guide on Same Procedure Exception for Tissue Products Federal Register notice: FDA makes available a guidance on “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” 11/20/2017

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