FDA Policy/General

Latest Federal Register Notices

Axiron Not Withdrawn Over Safety/Efficacy
Federal Register notice: FDA determines that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. 11/08/2018

Pilot Survey to Assess Allergy to Cosmetics
Federal Register notice: FDA seeks comments on a new proposed information collection entitled “Web-Based Pilot Survey To Assess Allergy to Cosmetics in the U.S.” 11/08/2018

Draft Guide on Drug Safety Meta-Analyses
Federal Register notice: FDA makes available a draft guidance entitled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.” 11/07/2018

Info Collection on Postmarket Drug Reporting
Federal Register notice: FDA submits to OMB a revised information collection on “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping.” 11/07/2018

Guide on Developing Fixed-Combination Hypertension Drugs
Federal Register notice: FDA makes available a final guidance entitled “Hypertension: Developing Fixed- Combination Drug Products for Treatment.” 11/07/2018

Info Collection Revision on Tropical Disease Vouchers
Federal Register notice: FDA seeks comments on an information collection revision for “Tropical Disease Priority Review Vouchers.” 11/06/2018

Info Collection Extension on Expanded Access Guide
Federal Register notice. FDA seeks comments on an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926” (OMB Control Number 0910-0814). 11/06/2018

FDA Guide on Device UDI Compliance Dates
Federal Register notice: FDA makes available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” 11/05/2018

Info Collection Extension for Biosimilar User Fees
Federal Register notice: FDA submits to OMB an information collection extension for “Biosimilars User Fee Program.” 11/05/2018

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