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

April 3, 2024
Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

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

March 7, 2024
Biopharma

USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...

Asia Biotech News, Asia Regulations, Biotech News, DSCSA Compliance, EU Regulatory, FDA Updates, Global Healthcare, Pharma Regulations, Singapore Healthcare, Swiss Medic

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

Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

March 5, 2024
Medical Device

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

New Developments in Treatment of Rare Diseases

February 22, 2024
Digital Health

Rare diseases are a complex of over 5000 pathologies representing 10% of the entire human pathology. The European Commission decided to consider those pathologies whose incidence does not exceed 5...

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