FDA Policy/General

Latest Federal Register Notices

Panel to Review Siga Tech Smallpox NDA
Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat. 04/13/2018

Info Collection Extension on Dispute Resolution
Federal Register notice: FDA submits for OMB approval an information collection extension for its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” 04/13/2018

Info Collection Extension for Accredited Persons Inspections
Federal Register notice: FDA submits to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program.” 04/13/2018

ICH Addendum to Pediatric Trial Guide
Federal Register notice: FDA makes available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” 04/12/2018

18 ANDAs No Longer Marketed are Withdrawn
Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants. 04/12/2018

Reagan-Udall Foundation Annual Meeting 5/4
Federal Register notice: FDA announces a 5/4 Reagan-Udall Foundation annual public meeting to discuss its activities and how it supports the agency. 04/12/2018

Consumer Reps Sought for Advisory Committees
Federal Register notice: FDA seeks the participation of consumer organizations in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels.04/11/2018

Comments Sought on Dietary Supplement Identity Tests
Federal Register notice: FDA seeks comments on an information collection extension for “Petition To Request an Exemption From 100% Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” 04/11/2018

Info Collection Extension on Condom Labeling
Federal Register notice: FDA submits for OMB approval an information collection extension for “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” 04/10/2018

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