FDA Policy/General

Latest Federal Register Notices

FDA Permanently Debars Kalinoski on ‘Filthy’ Drugs
Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. 03/20/2020

Tighe Permanently Debarred by FDA
Federal Register notice: FDA permanently debars Gerald Tighe from providing services related to an approved or pending drug product application. 03/20/2020

Edwards Permanently Debarred by FDA
Federal Register notice: FDA permanently debars Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pending drug product application. 03/20/2020

Guide on Cigarette Warnings
Federal Register notice: FDA makes available a final guidance entitled “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide.” 03/19/2020

Rule on Cigarette Health Warnings
Federal Register notice: FDA issues a final rule to establish new health warnings for cigarette packages and advertisements. 03/19/2020

Comments Reopened on Shared REMS Guide
Federal Register notice: FDA reopens the comment period for a 6/1/2018 notice on a shared system risk evaluation and mitigation strategy draft guidance. 03/19/2020

CDER Postpones, Cancels and Modifies Meetings
Federal Register notice: CDER lists certain meetings from 3/10 through 4/30 that are postponed, canceled, or modified to take place remotely. 03/19/2020

Guide on Liquid Drug Flow Restrictors
Federal Register notice: FDA makes available a draft guidance entitled “Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.” 03/18/2020

Lewicki Debarred for 5 Years
Federal Register notice: FDA debars Jagen Lewicki for five years from importing or offering for import any drug into the U.S. 03/18/2020

Daily Debarred for Illegal Kratom Imports
Federal Register notice: FDA debars Matthew Dailey for 10 years from importing or offering for import any drug into the U.S. 03/18/2020

3 NDAs Withdrawn Over No Annual Reports
Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports. 03/17/2020

Dong Debarred Over Stimulants in Supplements
Federal Register: FDA debars Zhang Xiao Dong for five years from importing articles of food (including dietary supplements) or offering such articles for importation into the U.S. 03/17/2020

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