Tag: Regulatory News

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

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

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

November 28, 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...

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

Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 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

October 26, 2023
Consumer Health

USA Canada Three New Food Enzymes Granted Approvals On October 11, 2023, Health Canada unveiled NOM/ADM-0209 with immediate effect, modifying the List of Permitted Food Enzymes to enable the...

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

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

October 18, 2023
Medical Device

ASIA INDIA The Indian Regulatory Authority (CDSCO) has released List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer...

ANVISA, Asia Regulatory News, Medical Devices, NMPA, Regulatory News, ROW Regulatory News, SaMD, SFDA

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

October 10, 2023
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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...

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