FDA Policy/General

Latest Federal Register Notices

Draft Guide on Rare Disease Gene Therapies
Federal Register notice: FDA makes available a draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” 07/12/2018

Guide on CMC Info for Gene Therapy Products
Federal Register notice: FDA makes available a draft guidance entitled “Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications.” 07/12/2018

Guide on Gene Therapies for Retinal Disorders
Federal Register notice: FDA makes available a draft guidance entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” 07/12/2018

Draft Guide on Hemophilia Gene Therapy Products
Federal Register notice: FDA makes available a draft guidance entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” 07/12/2018

Comments Sought on Formal PDUFA Meeting Guide
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products.” 07/11/2018

Draft Guide on Smallpox Antiviral Development
Federal Register notice: FDA makes available a draft guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” 07/11/2018

Info Collection Extension for Adverse Event Reporting
Federal Register notice: FDA seeks comments on an information collection extension for “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping” (OMB Control Number 0910-0230). 07/10/2018

Joint Panel to Review Fentanyl REMS Assessment
Federal Register notice: FDA has announced an 8/3 joint Advisory Committee meeting that will discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ REMS program. 07/10/2018

Panel to Review Insmed Lung Disease Drug
Federal Register notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting. 07/09/2018

Draft Guide on Drug Indications Labeling
Federal Register notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018

Comments Sought on Biosimilar Info Collection
Federal Register notice: FDA seeks comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications.” 07/09/2018

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