FDA Policy/General

Latest Federal Register Notices

Testing for Biotin Interference in IVDS
Federal Register notice: FDA makes available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” 06/14/2019

FDA Withdraws 12 No-longer Marketed ANDAs
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. 06/14/2019

FDA Seeks Advisory Panel Consumer Reps
Federal Register notice: FDA requests that any consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. 06/14/2019

Lumateperone Tosylate NDA for Schizophrenia to Panel
Federal Register notice: FDA announces a 7/31 Psychopharmacologic Drugs Advisory Committee meeting to discuss an Intra-Cellular Therapies schizophrenia NDA. 06/14/2019

Arthritis Advisory Committee to Review Ofev sNDA
Federal Register notice: FDA announces a 7/25 Arthritis Advisory Committee meeting to discuss a Boehringer Ingelheim supplemental NDA for Ofev (nintedanib) capsules. 06/13/2019

Guide on Mouse Embryo Assay for Reproduction Devices
Federal Register notice: FDA makes available a draft guidance entitled “Mouse Embryo Assay for Assisted Reproduction Technology Devices.” 06/13/2019

FDA Posts Information Collections Approved by OMB
Federal Register notice: FDA posts a list of information collections that have been recently approved by OMB. 06/12/2019

Information Collection on New Animal Drug Reporting
Federal Register notice: FDA seeks comments on an information collection extension entitled “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516.” 06/12/2019

Listing of Recent Information Collections Approved by OMB
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB. 06/11/2019

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