FDA Policy/General

Latest Federal Register Notices

Guide on Consensus Standards Recognition/Withdrawal
Federal Register notice: FDA makes available a draft guidance entitled “Recognition and Withdrawal of Voluntary Consensus Standards.” 09/14/2018

Draft Guide on 510(k) Third-Party Review Program
Federal Register notice: FDA makes available a draft guidance entitled “510(k) Third-Party Review Program.” 09/14/2018

FDA Posts ANDA Bioequivalence Study Guides
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that recommend bioequivalence study designs that are intended to support ANDAs. 09/14/2018

Guide on Voluntary Consensus Standards
Federal Register notice: FDA makes available a final guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” 09/14/2018

FDA Proposed Rule to Improve FOIA Process
Federal Register proposed rule: FDA proposes to amend current regulations to incorporate changes made to the Freedom of Information Act by recent laws. 09/13/2018

Science Board to Hear CVM Antibiotic Resistance Response
Federal Register notice: FDA announces a 10/22 public advisory committee meeting of its Science Board. that will hear a response from CVM on recommendations about antibiotic resistance monitoring. 09/13/2018

Proposed Rule on Device Electronic Submissions
Federal Register proposed rule: FDA proposes to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. 09/13/2018

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