Tag: Regulatory News

Consumer Health – USA/Europe/Asia/ROW Regulatory News – Sept 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, Public Health, Regulatory News

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

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

Biopharma

USA FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress...

Biotech Updates, Clinical Trials, Drug Safety, EMA, FDA, Global Health, Healthcare Regulations, Medical Devices, Pharma News, Regulatory News

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

Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”...

.Device Regulation, Compliance, EU, FDA, Global Health, Guidance, Health Care, June2024, Med Tech, Medical Devices, Regulatory News

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

Biopharma

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT),...

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News, Viral Safety Evaluation

Consumer Health-USA/Europe/Asia/ROW Regulatory News-Nov. 2023

Consumer Health

USA Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings The U.S. Food and Drug Administration published...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News