FDA Policy/General

Latest Federal Register Notices

Comments Sought on Developing CNS Stimulants
Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous system stimulants. 09/20/2019

Device Guidances Under Safety/Performance Pathway
Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency’ device Safety and Performance Based Pathway. 09/20/2019

Info Collection Extension on MedSun Reporting
Federal Register notice: FDA seeks comments on an information collection extension for it MedSun adverse event program for medical devices. 09/19/2019

Guide on Safer Technologies Device Program
Federal Register notice: FDA posts a draft guidance entitled “Safer Technologies Program for Medical Devices,” a new, voluntary program for certain devices and combination products that offer safer options than currently marketed products. 09/19/2019

Final Guide on 505(q) Citizen Petitions
Federal Register notice: FDA makes available a final guidance entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” 09/19/2019

Info Collection Extension for Post-market Studies
Federal Register notice: FDA seeks comments on an information collection extension for drug/biologic postmarketing studies status reports. 09/18/2019

Emergency Use Revoked for Luminex Zika Assay
Federal Register notice: FDA revokes an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay. 09/18/2019

53 Product-Specific Guidances for ANDAs
Federal Register notice: FDA makes available 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised ones. 09/17/2019

FDA Revokes Zika Test Emergency Authorization
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Siemens Healthcare Diagnostics for the Advia Centaur Zika test. 09/16/2019

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