FDA Policy/General

Latest Federal Register Notices

Draft Guide on Including Older Patients in Trials
Federal Register notice: FDA makes available a draft guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” 03/06/2020

Policy for Coronavirus Testing Labs
Federal Register notice: FDA makes available a final guidance entitled “Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.” 03/06/2020

CDER Regulatory Project Management Site Tours
Federal Register notice: CDER announces its decision to continue Regulatory Project Management Site Tours and Regulatory Interaction Program. 03/06/2020

Electrical Stimulation Device Ban
Federal Register notice: FDA finalizes a ban on electrical stimulation devices for self-injurious or aggressive behavior. 03/06/2020

Exocrine Pancreatic Insufficiency NDA Guide Withdrawn
Federal Register notice: FDA withdraws its 2006 guidance entitled “Exocrine Pancreatic Insufficiency Drug Products — Submitting NDAs.” 03/05/2020

Regulatory Review Period for Ingrezza
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Neurocrine Biosciences’ Ingrezza (valbenazine tosylate). 03/05/2020

Q & A Guide on ‘Deemed to be a License’
Federal Register notice: FDA makes available a guidance entitled “The ‘Deemed To Be a License’ Provision of the BPCI Act: Questions and Answers.” 03/05/2020

Purple Book Enhancements in First Phase
Federal Register notice: FDA announces the completion of the first phase of its enhanced Purple Book for biologics. 03/05/2020

Info Collection on GMPs for Medicated Feeds
Federal Register notice: FDA seeks comments on an information collection extension for medicated feed GMPs. 03/04/2020

Regulatory Review Period for Kyowa Asthma Drug
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Kyowa Hakko Kirin’s Fasenra (benralizumab). 03/04/2020

Guide on Contacts Performance Criteria
Federal Register notice: FDA makes available a draft guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses — Performance Criteria for Safety and Performance Based Pathway.” 03/04/2020

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