FDA Policy/General

Latest Federal Register Notices

Draft Guide on ANDA Pre-submission Facility Info
Federal Register notice: FDA makesavailable a revised draft guidance entitled “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” 11/06/2017

Bayer’s Revex Not Withdrawn Due to Safety/Effectiveness
Federal Register notice: FDA determines that Bayer’s Revex (nalmefene hydrochloride injection), which is indicated for reversing an opioid overdose, was not withdrawn due to safety or effectiveness issues. 11/03/2017

Draft Guide on Controlled Correspondence for Generics
Federal Register notice: FDA makes available a draft guidance on “Controlled Correspondence Related to Generic Drug Development.” 11/03/2017

FDA Renews Patient Engagement Advisory Committee for 2 Years
Federal Register notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years. 11/02/2017

Comments Sought on Radiopharmaceuticals Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — OMB Control Number 0910-0409.” 11/02/2017

Nominations Sought for Pediatric Advisory Committee Rep
Federal Register notice: FDA seeks nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committee. 11/02/2017

Public Meeting on FDA Hiring and Retention
Federal Register notice: FDA announces an 11/30 public meeting on “Assessment of FDA Hiring and Retention” that will share high-level findings from a recently completed examination of the agency’s hiring process conducted by an independent contractor. 11/02/2017

Draft ICH Guidance on Drug Trial Statistical Principles
Federal Register notice: FDA makes available an International Council for Harmonization draft guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” 11/01/2017

Workshop on Opioid Packaging/Storgage/Disposal
Federal Register notice: FDA announces a 12/11-12 public workshop on “Packaging, Storage, and Disposal Options To Enhance Opioid Safety — Exploring the Path Forward.” 11/01/2017

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