FDA Policy/General

Latest Federal Register Notices

2 Guides on Drug Interaction Studies
Federal Register notice: FDA releases two final guidances on drug interaction studies. 02/7/2020

Priority Review Voucher for Vyondys 53 Approval
Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys 53 (golodirsen) for treating Duchenne muscular dystrophy. 02/7/2020

Draft Guide for Levonorgestrel ANDAs
Federal Register notice: FDA makes available a revised draft guidance entitled “Draft Guidance for Levonorgestrel. 02/6/2020

Oncologic Panel to Review 2 Product Submissions
Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting that will discuss a Steba Biotech NDA for prostate cancer and an Eli Lilly supplemental BLA for Cyramza (ramucirumab) for use in combination with erlotinib in lung cancer patients. 02/6/2020

Animal User Fee Reporting Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees.” 02/5/2020

Info Collection on Electronic Product Radiation
Federal Register notice: FDA seeks comments on an information collection extension for “Electronic Products — 21 CFR Parts 1000 Through 1050.” 02/5/2020

Cardene Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Chiesi USA’s Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for safety or effectiveness reasons. 02/4/2020

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