FDA Policy/General

Latest Federal Register Notices

Draft Guide on Kidney Transplantation Drugs 03/24/2017
Federal Register notice: FDA announces the availability of a draft guidance on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.

CDRH Seeks Experiential Learning Program Players 03/23/2017
Federal Register notice: CDRH announces its 2017 Experiential Learning Program, a training component that is intended to provide Center staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges industry faces.

Conference on Generic Drug Development 03/22/2017
Federal Register notice: FDA announces a two-day (4/4-5) public conference entitled “FDA CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Generic Drugs Forum.”

FDA Comments Sought on Custom Device Reporting 03/21/2017
Federal Register Notice: FDA seeks comments on an information collection extension for “Annual Reporting for Custom Device Exemption.”

FDA Delays for 1 Year Intended Use Final Rule 03/20/2017
Federal Register Notice: FDA delays until 3/19/2018 the effective date of its final rule on “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’”

Workshop Transcript on Cell Therapy Workshop 03/20/2017
Federal Register notice: FDA corrects a 12/29/2016 notice about a public workshop entitled “Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.”

Comments Sought on Device ‘Corrections and Removals’ Reporting 03/20/2017
Federal Register notice: FDA seeks comments on a information collection extension entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806.

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