FDA Policy/General

Latest Federal Register Notices

Review Period Determined for Giapreza
Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceutical’s Giapreza (angiotensin II). 09/06/2019

Guide on Pediatric Partial Onset Seizures
Federal Register notice: FDA makes available a final guidance entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients Two Years of Age and Older.” 09/06/2019

Info Collection Extension for GCP Guide
Federal Register notice: FDA seeks comments on an information collection extension for “Guidance for Industry on E6 (R2) Good Clinical Practice; International Council for Harmonization; Integrated Addendum to ICH E6 (R1).” 09/06/2019

Info Collection Extension for Patent Submissions
Federal Register notice: FDA submits to OMB an information collection extension for NDA patent submission and listing requirements. 09/05/2019

Proposal to Add 5 Bulk Drugs for Compounding
Federal Register proposed rule: FDA proposes to add five additional bulk drug substances to its drug compounding list. 09/05/2019

Info Collection Extension for PET Drug GMPs
Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs. 09/04/2019

Panel to Discuss Duodenoscope Sterilization
Federal Register notice: FDA announces an 11/6-7 Advisory Committee meeting to discuss industrial ethylene oxide sterilization of medical devices, including reprocessed duodenoscopes. 09/04/2019

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