FDA Policy/General

Latest Federal Register Notices

Mutamycin Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effectiveness. 06/11/2018

Correction on Product Classification Proposed Rule
Federal Register notice: FDA corrects a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products. 06/08/2018

FDA Workshop on Developing Inhaled Antibacterial Drugs
Federal Register notice: FDA announces a 6/27 public workshop entitled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.” 06/08/2018

Intramedullary Fixation Rod Placed Into Class 2
Federal Register notice: FDA classifies the in vivo cured intramedullary fixation rod into Class 2 (special controls). 06/08/2018

Info Collection Extension Sought for Device eMDR Submissions
Federal Register notice: FDA submits a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requirements. 06/08/2018

Modifications to FDA Recognized Consensus Standards
Federal Register notice: FDA publishes modifications to its list of standards the agency recognizes for use in premarket reviews (FDA Recognized Consensus Standards). 06/07/2018

Panel to Review GSK COPD Add-on Therapy
Federal Register notice: FDA announces a 7/25 Pulmonary-Allergy Drugs Advisory Committee meeting. 06/06/2018

Sun Pharma Not Withdrawing Benazepril HCl/Hydrochlorothiazide
Federal Register notice: FDA corrects a 2/23 notice announcing that Sun Pharmaceutical Industries asked to withdraw its generic benazepril hydrochloride and hydrochlorothiazide tablets. 06/06/2018

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