FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period for Shionogi’s Symproic
Federal Register notice: FDA determines the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain. 04/12/2019

Class 2 for Ventilatory Electrical Impedance Tomograph
Federal Register notice: Based on a de novo request, FDA classifies Timpel’s Enlight 1810 ventilatory electrical impedance tomograph into Class 2. 04/12/2019

Device Accessories Into Class 1
Federal Register notice: FDA classifies suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017. 04/12/2019

Final Rule on OTC Hand Sanitizers
Federal Register final rule: FDA rules that certain active ingredients are not allowed to be used in OTC hand sanitizers. 04/11/2019

Comments Extended on Tobacco Compliance Policy Guide
Federal Register notice: FDA extends the comment period on a draft guidance entitled “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” 04/09/2019

Oncologic Drugs Panel to Discuss 2 Daiichi NDAs
Federal Register notice: FDA announces a 5/14 Oncologic Drugs Advisory Committee meeting to discuss two Daiichi Sankyo NDAs. 04/08/2019

Panel to Discuss Drug Renal Impairment Evaluations
Federal Register notice: FDA announces a 5/7 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. 04/08/2019

Antivert Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Casper Pharma’s Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reasons of safety or effectiveness. 04/08/2019

Final Guide on REMS Factors
Federal Register notice: FDA makes available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” 04/05/2019

Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. 04/05/2019

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