Tag: Regulatory News

Pharma – Asia, S America, MENA, ROW Regulatory News – March 2025

Biopharma

ARGENTINA ANMAT in numbers: Advertising Monitoring and Inspection Program The Program for Monitoring and Oversight of Advertising and Promotion of Products Subject to Health Surveillance is...

Drug Approvals, Drug Safety, Global Health, Healthcare Policy, Medical Regulations, Pharma Compliance, Pharma Industry, Pharma Regulations, Pharma Updates, Regulatory News

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

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

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled medical devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

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

Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

Consumer Health

USA CANADA. Health Canada Grants Approvals for Three New Food Enzymes On October 11, 2023, Health Canada announced NOM/ADM-0209, effective immediately, which modifies the List of Permitted Food...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

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

Biopharma

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current...

Biotech Regulatory News, Combination Products, EU Regulatory News, Marketing Authorisation, Pharma Regulatory News, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

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

Tag: Regulatory News

Pharma – Asia, S America, MENA, ROW Regulatory News – March 2025

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

Medical Devices-USA/Europe Regulatory News – Nov 2023

Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

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

Medical Devices-USA/Europe Regulatory News-October 2023

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