FDA Policy/General

Latest Federal Register Notices

Information Collection Extension for CVM Dispute Resolution
Federal Register notice: FDA submits for OMB approval an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine.” 02/09/2018

Information Collection Extension for ADR eSubmission Waivers
Federal Register notice: FDA submits for OMB approval an information collection extension request for “Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements.” 02/09/2018

Regulatory Review Determined for Jublia
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Kaken Pharmaceutical Co.’s Jublia (efinaconazole) is 2,521 days. 02/08/2018

Regulatory Review For AstraZeneca’s Farxiga
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for AstraZeneca’s Farxiga (dapagliflozin) is 3,673 days. 02/07/2018

Regulatory Review for Gilead’s Genvoya
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Gilead Sciences’ Genvoya is 5,031 days. 02/07/2018

Regulatory Review for Sedasys System
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Scott Laboratories’ Sedasys System is 2,816 days. 02/07/2018

Regulatory Review Period Determined for Blincyto
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Amgen’s Blincyto (blinatumomab) is 2,850 days. 02/06/2018

Information Collection Revision on Expedited Programs Guide
Federal Register notice: FDA submits to OMB a revised information collection entitled “Guidance for Industry: Expedited Programs for Serious Conditions — Drugs and Biologics.” 02/06/2018

Percutaneous Nerve Stimulator for Substance Disorder in Class 2
Federal Register notice: FDA classifies the percutaneous nerve stimulator for substance use disorders into Class 2 (special controls). 02/05/2018

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

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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