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ANVISA Updates Importation Law: Key Changes

Standards

The introduction of RDC 751/2022 was significant for the Medical Device industry because it revised Brazil’s regulatory framework after two decades of validity. Despite the controversy surrounding...

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

Understanding FDA Labeling Regulations

All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The U.S. Food and Drug Administration (FDA) holds that labeling...

Compliance Guide, Drug Labeling, FDA, Labeling Guidelines, Labeling Regulations

Role of Technology in Regulatory Intelligence

Digital Health

Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing,...

Artificial Intelligence, Compliance, Health Tech, Healthcare, Healthcare Industry, Regulatory Intelligence

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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current...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