Author: admin

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

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

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations

Consumer Health – USA, UK, Asia and ROW Regulatory News – Aug 2024

September 4, 2024
Consumer Health

USA FDA Starts Next Phase of Sodium Reduction Efforts FDA took another important step in its sodium reduction efforts. The agency has issued new, voluntary targets for sodium reduction in foods...

FDA News, Food Regulations, Food Safety, FSSAI, Global Regulatory News, Health News, Regulatory Updates

Consumer Health – USA/Europe/Asia/ROW Regulatory News – July 2024

August 7, 2024
Consumer Health

USA FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food The U.S. Food and Drug Administration (FDA) is revoking the regulation authorizing the use of brominated...

Consumer Health, Consumer Safety, FDA News, Food Labeling, Food Regulations, Food Safety, Health Concerns

Medical Devices – USA, Europe and ROW Regulatory News – July 2024

August 6, 2024
Medical Device

USA Medical Device User Fee Rates for Fiscal Year 2025 The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for the fiscal year...

Clinical Guidance, Clinical Updates, Device Regulation, Medical Devices, Medical News, Medical Regulations, Regulatory Updates

European Health Data Space’s implications for “Wellness Apps” & Medical Devices

July 30, 2024
Medical Device

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at: 1. Empowering individuals...

AI in Healthcare, Digital Health, Electronic Health Records (EHR), GDPR Compliance, Health Data Security, HealthTech Regulations, Medical Devices, Preventive Healthcare, Wellness Apps