Tag: Asia Regulations

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

October 7, 2024
Biopharma

USA FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral...

Asia Regulations, Drug Approvals, EMA, Europe Pharma, FDA, Global Health, Safety Updates, USA Drug 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

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USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...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