Tag: Regulatory Updates

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

Biopharma

USA EPA, FDA, and USDA Release Joint Biotechnology Regulatory Plan In alignment with President Biden’s Executive Order 14081, the EPA, FDA, and USDA have issued a coordinated plan to modernize...

Bio Pharma, Bio Tech, Biotech News, Biotechnology, Drug Approval, EMA, FDA, Global Health, Health News, Healthcare, Healthcare Innovation, Medical Updates, Pharma Industry, Pharma News, Pharma Regulations, Pharma Trends, Pharma2024, Pharmaceuticals, Regulatory Updates

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

Consumer Health

USA Infant Formula Safety and Oversight Infant formula remains a vital source of nutrition for many babies in the United States, and the FDA continues to prioritize ensuring its safety and nutritional...

Consumer Health, Consumer Protection, Food Quality, Food Regulations, Food Safety, Food Safety News, Health And Safety, Health News, Health Policy, Health Regulations, Health Standards, May2024, Public Health, Regulatory Updates, Safety Efforts

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

Medical Device

USA FDA Issues Guidance on Remanufacturing of Medical Devices The FDA has released final guidance intended to clarify when activities performed on a medical device may be considered “remanufacturing.”...

Compliance, eCTD, Global Health, Health Policy, IVDs, Medical Devices, Medical Technology, Regulations, Regulatory Updates

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

Consumer Health

USA FSIS Issues Updated Guidance on Label Approval The FSIS has released updated guidance to help establishments determine whether product labels require review by the Labeling and Program Delivery...

Consumer Health News, Food Safety, FSIS Guideline, Health Regulations, Healthcare News, Labeling Guidelines, Regulatory Updates, Standards

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

Biopharma

USA FDA Final Guidance on Electronic Safety Report Submissions The FDA has released three final guidance documents addressing electronic submissions for adverse event reporting. These cover IND...

BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates

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

Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The FDA’s Center for Devices and Radiological Health (CDRH) continues encouraging device sponsors to rely on FDA‑recognized voluntary...

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