FDA Policy/General

16 Information Collections Cleared by OMB

Federal Register notice: FDA has published a list of 16 information collections approved by OMB. They are:

Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States
Postmarket Surveillance of Medical Devices
Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Experimental Study on Measuring Consumer Comprehension of Displaysof Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Medical Devices; Current Good Manufacturing Practice Quality System Regulation
Threshold of Regulationfor Substances Used inFood-Contact Articles
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Format and Content Requirements for Over-the-Counter Drug Product Labeling
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Guidance for Tobacco Retailers on Tobacco Retailer Training Programs
Dear Health Care Provider Letters: Improving Communication of Important Safety Information
Requests for Feedback on Medical DeviceSubmissions
Data to Support Social and Behavioral Research as Used by the Food and Drug Administration

To view the notice, click here.

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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