FDA Policy/General

Latest Federal Register Notices

Info Collection Extension for In Vivo Radiopharmaceuticals Regs
Federal Register notice: FDA sends for OMB approval an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.” 03/23/2018

Antimicrobial Drugs Panel Meeting on Achaogen NDA
Federal Register notice: FDA announces a 5/2 Antimicrobial Drugs Advisory Committee meeting on an Achaogen NDA for plazomicin. 03/23/2018

CBER Science Symposium Planned for June
Federal Register notice: FDA announces a 6/25-26 public symposium entitled “2018 Center for Biologics Evaluation and Research Science Symposium.” 03/22/2018

Several Information Collections Approved by OMB
Federal Register notice: FDA announces OMB approval of several information collections. 03/22/2018

Draft Guide on Postmarketing Safety Reporting
Federal Register notice: FDA makes available a draft guidance entitled “Postmarketing Safety Reporting for Combination Products.” 03/21/2018

Guide on Combo Product Safety Reporting Compliance
Federal Register notice: FDA makes available an immediately in effect guidance entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” 03/21/2018

Comments Extended on Homeopathic Drug Guidance
Federal Register notice: FDA extends by 60 days the comment period on a 12/20/2017 Federal Register notice entitled “Drug Products Labeled as Homeopathic; Draft Guidance.” 03/20/2018

Guide on ‘Small Business’ Determination
Federal Register notice: FDA makes available a draft guidance on how to determine the number of employees for purposes of a “small business” definition. 03/19/2018

Public Workshop on Pathways to Global Unity
Federal Register notice: FDA announces a 6/11-12 public workshop on “Pathways to Global Unity.” 03/19/2018

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