FDA Policy/General

Latest Federal Register Notices

Guide on Retroviral Vector-Based Gene Therapies
Federal Register notice: FDA makes available a final guidance on testing retroviral vector-based human gene therapy products. 01/31/2020

Guide on Gene Therapy Observational Studies
Federal Register notice: FDA makes available a final guidance entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products.” 01/31/2020

Guide on Creutzfeldt-Jakob Disease Risk Reductions
Federal Register notice: FDA makes available a draft guidance on recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease. 01/31/2020

Guide on CMC Info for Gene Therapies
Federal Register notice: FDA released a final guidance on Chemistry, Manufacturing, and Control information for gene therapy INDs. 01/30/2020

Hemophilia Gene Therapy Development Guide
Federal Register notice: FDA posts a final guidance on human gene therapy development for hemophilia. 01/30/2020

Draft Guide on Gene Therapy Sameness
Federal Register notice: FDA makes available a draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” 01/30/2020

Guide on Retinal Disorder Gene Therapy Development
Federal Register notice: FDA posts a final guidance on human gene therapy for retinal disorders. 01/30/2020

Final Guide on Rare Disease Gene Therapies
Federal Register notice: FDA makes available a final guidance on rare disease gene therapy development. 01/30/2020

Voting Members Needed for CDRH Patient Panel
Federal Register notice: FDA requests nominations for voting members to serve on CDRHֺֺ’s Patient Engagement Advisory Committee. 01/29/2020

16 Information Collections Cleared by OMB
Federal Register notice: FDA posts a list of 16 information collections approved by OMB. 01/29/2020

DTC Study on Ad Endorser Influence
Federal Register notice: FDA seeks comments on a proposed study entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” 01/28/2020

Guide on Arthroscopy Pump Tubing Sets
Federal Register notice: FDA makes available a draft guidance entitled “Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use — Premarket Notification (510(k)) Submissions.” 01/28/2020

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