Tag: FDA

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2024

October 7, 2024
Medical Device

USA Air Powered Dental Handpieces and Air Motors – Performance Criteria for Safety and Performance Based Pathway The devices covered by this guidance include dental air-powered handpieces, air...

FDA, Medical Device Compliance, Medical Devices, Performance Standards, Regulatory News, Safety Guidelines

Consumer Health – USA/Europe/Asia Regulatory News – Feb. 2024

March 6, 2024
Consumer Health

USA New Directory of Ingredients Used in Products Marketed as Dietary Supplements The U.S. Food and Drug Administration (FDA) has updated the agency’s Ingredient Directory, including renaming...

Asia Health, BPA, Consumer Health News, Dietary Supplements, EUHealth, FDA, February2024, Global Health, Health Regulations, Healthcare News, Medical Guidelines, Regulatory Updates

Consumer Health USA/Asia/ROW Regulatory News – Jan 2024

February 8, 2024
Consumer Health

USA FDA announces availability of Additional Submission Tools for Cosmetic Facility Registration and Product Listing The U.S. Food and Drug Administration (FDA) officially launched additional...

Asia Regulations, Consumer Health, FDA, Regulatory Updates, ROW Imports

Understanding FDA Labeling Regulations

October 18, 2023
OTC

All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. FDA holds that labeling encompasses: Any written, printed...

Compliance Guide, Drug Labeling, FDA, Labeling Guidelines, Labeling Regulations

Pharma/Biotech – USA, Europe Regulatory News, July 2023 Vol. 1

July 12, 2023
Biopharma

USA No Big-Picture Impact for Manufacturers in CMS IRA Updates In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price...

Biotech Regulatory News, EMA, EU Regulatory News, FDA, GCP Guideline, MHRA, Pharma Regulatory News, Regulatory News, RWD, RWE, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News