FDA Policy/General

Latest Federal Register Notices

Info Collection Extension Sought for Drug GMP Regs
Federal Register notice: FDA submits for OMB approval an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR parts 210 and 211).” 04/06/2018

FDA Science Board to Meet 4/23
Federal Register notice: FDA announces a 4/23 Science Board Advisory Committee to hear a report from CBER and the committee’s Research Program Review Subcommittee. 04/06/2018

Comments Sought on Drug Exposure-response Analyses
Federal Register notice: FDA seeks comments on the drug industry’s use of exposure-response analyses, particularly as it relates to recommendations in a 2003 guidance entitled Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications. 04/05/2018

Guide on Liposome Drug Products
Federal Register notice: FDA makes available a guidance entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” 04/05/2018

Aninal Drug Regulations Amended to Reflect Approvals, Etc.
Federal Register Final Rule: FDA amends the animal drug regulations to reflect recent application-related actions for NADAs and ANADAs. 04/04/2018

5 NDAs Withdrawn by FDA
Federal Register notice: FDA withdraws approval of five NDAs because the drug products are no longer marketed. 04/03/2018

Editorial, Typographical Corrections in Device Regs
Federal Register Final Rule; technical amendment: FDA amends certain medical device regulations to correct editorial issues, such as typographical errors, and to ensure accuracy and clarity in the regulations. 04/03/2018

FDA Orders PEG 3350 ANDAs Off Market Due to OTC Switch
Federal Register notice: FDA issues an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene glycol 3350 because the drug products are misbranded. 04/02/2018

Draft 5-Year Plan on Implementing Benefit-Risk Assessments
Federal Register notice: FDA makes available a draft five-year plan describing its approach to further implement a structured benefit-risk assessment that includes the patient’s voice in drug development and decision-making. 04/02/2018

How Industry Can Submit Proposed Guidances
Federal Register Final Rule; technical amendment: FDA amends its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the agency. 04/02/2018

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

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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