FDA Policy/General

Latest Federal Register Notices

Draft Guide on Hepatitis B Drugs
Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” 11/02/2018 Workshop on Hemophilia Product Development
Federal Register notice: FDA announces a 12/6 public workshop entitled “Product Development in Hemophilia.” 11/02/2018 Class 2 for Meprobamate Test System
Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls). 11/01/2018 Insulin Therapy Adjustment Devices into Class 2
Federal Register notice: FDA classifies insulin therapy adjustment devices into Class 2 (special controls). 11/01/2018 2 Medical Device Proposed Rules Scrapped
Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered viable candidates for final action. 11/01/2018 FDA Science Advisory Board Meeting 12/4-5
Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Research. 10/31/2018 Information Collection Extension for Bar Code Labels
Federal Register notice: FDA seeks comments on an information collection extension entitled “Bar Code Label Requirement for Human Drug and Biological Products.” 10/31/2018 Draft Guide on Dried Plasma Products
Federal Register notice: FDA makes available a draft guidance entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion.” 10/30/2018 10 NDA Approvals Withdrawn by FDA
Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. 10/30/2018

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