FDA Policy/General

Latest Federal Register Notices

Tzvi Lexiere Debarred for 10 Years
Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. 11/27/2019

Six ANDAs Withdrawn by FDA
Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. 11/27/2019

Draft Guide on Biosimilar Clinical Immunogenicity
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” 11/27/2019

Device Sterilization Master File Pilot
Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers to submit a master file when making certain changes. 11/26/2019

Tobacco Product Modifications Compliance Policy
Federal Register notice: FDA makes available a guidance entitled “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” 11/26/2019

FDA Reopens Tobacco Product Comment Period
Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applications and recordkeeping requirements. 11/25/2019

FDA Guidances for Generic Drug Developers
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers. 11/25/2019

Info Collection for Fellowship/Trainee Programs
Federal Register notice: FDA seeks comments on a proposed information collection for “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” 11/25/2019

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