FDA Policy/General

Latest Federal Register Notices

Comments Sought on Real World Evidence Program
Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. 12/07/2018

Proposed Rule on De Novo Classification Process
Federal Register proposed rule: FDA proposes to establish requirements for its medical device De Novo classification process. 12/07/2018

Draft Guide on Companion Diagnostics
Federal Register notice: FDA makes available a draft guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” 12/07/2018

Draft Guide on Blood Bacterial Rick Controls
Federal Register notice: FDA makes available a draft guidance entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.” 12/06/2018

Info Collection Extension for Environmental Impact Considerations
Federal Register notice: FDA submits to OMB an information collection extension entitled “Environmental Impact Considerations.” 12/06/2018

Info Collection Extension for Drug Supply Chain Guide
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” 12/05/2018

InSightecs Exablate Regulatory Review Period Determined
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for InSightec’s medical device Exablate. 12/05/2018

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