Tag: Regulatory News

Consumer Health – USA/UK/Asia/ROW Regulatory News – Feb 2025

March 12, 2025
Consumer Health

USA Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate...

Consumer Health, FDA, February 2025, Food Regulations, Food Safety, Global Health Compliance, Health Updates, Product Safety, Regulatory News

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

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

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/ROW Regulatory News – Sept 2024

October 7, 2024
Consumer Health

USA Youth E-Cigarette Use Drops to Lowest Level in a Decade Half a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National...

Compliance News, Food Industry, Food Safety, Health And Safety, Health Updates, International Standards, Public Health, Regulatory News

Pharma/Biotech – USA, UK, Asia and ROW Regulatory News – Aug 2024

September 5, 2024
Biopharma

USA FDA Approves First Nasal Spray for Treatment of Anaphylaxis The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions...

COVID19 Vaccines, Drug Updates, FDA Approvals, Healthcare News, Medical News, Overdose Treatment, Pharma Updates, Regulatory News, Regulatory Updates