FDA Policy/General

Latest Federal Register Notices

Comments Sought on Condom Labeling Info Collection
Federal Register notice: FDA seeks comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” 11/09/2017

Upcoming Blood Products Advisory Committee Meeting
Federal Register notice: FDA announces an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting. 11/09/2017

Draft Guide on Using DMF for Shared REMs Submission
Federal Register notice. FDA makes available a draft guidance for industry on “Use of a Drug Master File for Shared System REMS Submissions.” 11/09/2017

Guide on Recurrent Herpes Labialis Drug Development
Federal Register notice: FDA makes available a guidance on “Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Prevention.” 11/08/2017

Proposed Info Collection on Target Product Profile Guide
Federal Register notice: FDA submits to OMB a new proposed information collection supporting its “Draft Guidance for Industry and Review Staff on Target Product Profile — A Strategic Development Process Tool.” 11/08/2017

Comments Sought on Info Collection for Expedited Product Programs
Federal Register notice: FDA seeks comments on an information collection revision for its “Guidance for Industry on Expedited Programs for Serious Conditions — Drugs and Biologics OMB Control Number 0910 – 0765. 11/08/2017

CDER Seeking Input on Study Data Template
Federal Register notice: CDER seeks comments on a proposed “Analysis Data Reviewer’s Guide” (ADRG) template that was developed under an ongoing collaboration with the Pharmaceutical Users Software Exchange for submitting study data. 11/08/2017

Vitamin D Mass Spectrometry Test Put Into Class 2
Federal Register notice: FDA classifies the total 25-hydroxyvitamin D mass spectrometry test system into Class 2 (special controls). 11/07/2017

Class 2 for Recessive Carrier Screening Gene Mutation Detectors
Federal Register final order: FDA exempts from premarket notification requirements autosomal recessive carrier screening gene mutation detection systems. 11/07/2017

Class 2 for Health Risk Assessment Systems
Federal Register notice: FDA classifies genetic health risk assessment systems into Class 2 (special controls). 11/07/2017

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