Tag: FDA

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Biopharma

USA FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet...

Approval Healthcare Updates, Biotech News, Cancer Treatment, Drug Approval, FDA, Medical Advancements, Medicines, Patient Care, Pharma News, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Sept 2024

October 7, 2024
Biopharma

USA FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral...

Asia Regulations, Drug Approvals, EMA, Europe Pharma, FDA, Global Health, Safety Updates, USA Drug Updates

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