FDA Policy/General

Latest Federal Register Notices

Info Collection on Testing FDA Communications
Federal Register notice: FDA seeks comments on a new proposed information collection entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” 08/31/2018

Info Collection Extension of Device Labeling
Federal Register notice: FDA submits to OMB an information collection extension entitled “Medical Device Labeling Regulations — 21 CFR Parts 800, 801, and 809.” 08/31/2018

Pilot Meetings for Innovative Trial Designs
Federal Register notice: FDA announces a pilot meeting program to allow sponsors to discuss the use of complex innovative trial design approaches in medical product development. 08/30/2018

Comments Extended for Shared REMS Guide
Federal Register notice: FDA reopens for 14 days the comment period on its draft guidance entitled “Development of a Shared System Risk Evaluation and Mitigation Strategy.” 08/29/2018

FDA Adds 4 Tropical Disease Designations
Federal Register notice: FDA determines that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy its tropical disease definition. 08/27/2018

Pneumocystis Pneumonia Not a Tropical Disease: FDA
Federal Register notice: FDA determines that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical disease. 08/27/2018

Pharmaceutical Quality Site Visit Program
Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. 08/24/2018

Plasma Lyte Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that Plasma – Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety or effectiveness. 08/24/2018

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