FDA Policy/General

Latest Federal Register Notices

Info Collection Extension for REMS Requirements
Federal Register notice: FDA seeks comments on an information collection extension entitled “Prescription Drug Product Labeling; Medication Guide Requirements.” 10/26/2018

Comment Period Reopened on Sucralfate Guide
Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on sucralfate that appeared in a 10/20/2017 notice. 10/26/2018

Draft Guide on Biopharmaceutics Classification System Biowaivers
Federal Register notice: FDA makes available a draft guidance entitled “Biopharmaceutics Classification System-Based Biowaivers” that was prepared by the International Council for Harmonization. 10/26/2018

Regulatory Review Period Determined for Taltz
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lilly’s Taltz (ixekizumab). 10/26/2018

Drug Development Testicular Toxicity Guide
Federal Register notice: FDA makes available a guidance entitled “Testicular Toxicity: Evaluation During Drug Development.” 10/25/2018

Draft Guide on Drug Supplier Verification Systems
Federal Register notice: FDA makes available a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” 10/25/2018

Priority Voucher Awarded to Leadiant Bioscience
Federal Register notice: FDA awards a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revcovi (elapegademase-lvlr) injection meets the award criteria. 10/25/2018

Joint Panel to Mull Increasing Naloxone in Communities
Federal Register notice: FDA announces a 12/17 joint advisory committee meeting to discuss strategies to increase the availability of naloxone products intended for use in communities. 10/24/2018

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

Read more

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