FDA Policy/General

Latest Federal Register Notices

Draft Guide on Product Tracing Standardized Data
Federal Register notice: FDA makes available a draft guidance on “Standardization of Data and Documentation Practices for Product Tracing.” 03/02/2018

Guide on Genomic Sampling and Managing Data
Federal Register notice: FDA makes available a guidance entitled “E18 Genomic Sampling and Management of Genomic Data.” 03/02/2018

FDA/Canada Joint ICH Regional Meeting
Federal Register notice: FDA announces a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” 03/02/2018

Comments Sought on Susceptibility Test Interpretive Criteria
Federal Register notice: FDA reopens a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal drugs provided by FDA on its Susceptibility Test Interpretive Criteria Web page established 12/13/2017. 03/01/2018

Panel Meeting to Review Glucose Monitor
Federal Register notice: FDA announces a 3/29-30 Clinical Chemistry and Clinical Toxicology Devices Panel meeting. 02/28/2018

Information Collection Extension on Orphan Product Meetings
Federal Register notice: FDA submits for OMB approval an information collection extension for “Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development.” 02/28/2018

Class 2 for Lynch Syndrome Test Systems
Federal Register notice: FDA classifies Lynch syndrome test systems into Class 2 (special controls). 02/27/2018

Correction: FDA Says Baxter Clinolipid NDA Not Withdrawn
Federal Register notice: FDA corrects a 6/21/2017 Federal Register notice that incorrectly announced the withdrawal of a Baxter Healthcare NDA for Clinolipid 20%. 02/27/2018

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