FDA Policy/General

18 FDA Info Collections Ok’d by OMB

Federal Register notice: FDA is publishing a list of 18 information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. They are:

Premarket Notification Submission 510(k), Subpart E
Good Manufacturing Practice Regulations for Type A Medicated Articles
Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion
Endorser Status and Actual Use in Direct-to-Consumer Television Ads
Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages
Imports and Electronic Import Entries
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and Lookback
Administrative Practices and Procedures; Formal Hearings
Adverse Experience/Events with Approved New Animal Drugs
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
Human Cells, Tissues, and Cellular and Tissue-Based Products
New Animal Drugs for Minor Use and Minor Species
Potential Tobacco Product Violations Reporting Form
Food and Drug Administration Advisory Committee Regulations
Accreditation Scheme for Conformity Assessment Program
Quantitative Research on Front of Package Labeling on Packaged Foods
Current Good Manufacturing Practice Regulations for Medicated Feed
Medical Devices--Voluntary Improvement Program

To view the notice, click here.

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’

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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