Tag: Regulatory News

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

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

December 7, 2023
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

December 7, 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

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

November 28, 2023
Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News