FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period Determined for Vraylar
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. 01/26/2018

Regulatory Review Period Determined for Varubi
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for OPKO Health’s Varubi (rolapitant) to be 3,070 days. 01/26/2018

Pharma Science Panel Renewed
Federal Register notice: FDA announces that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional two years beyond the charter expiration date. 01/25/2018

Rule Issued on Biologic Inspection Timing, Requirements
Federal Register direct final rule: FDA amends its general biologics regulations relating to time of inspection requirements and to remove duties of inspector requirements. 01/25/2018

Comments Extended on 510(k)/CLIA App Studies
Federal Register notice: FDA extends the comment period on a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” 01/25/2018

Joint Panel to Meet on Drug Study for Treating Achondroplasia
Federal Register notice: FDA announces a 3/22 joint Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting. 01/23/2018

Timetable for e-Study Data Submissions
Federal Register notice: FDA announces a timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs and certain INDs. 01/23/2018

Comments Extended on ‘Least Burdensome’ Device Guide
Federal Register notice: FDA extends the comment period on a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles.” 01/23/2018

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