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Medical Devices–Asia Regulatory Updates Roundup, Aug 2022

September 7, 2023
Medical Device

INDIA (CDSCO) List of Notified Bodies registered with CDSCO under MDR, 2017 CDSCO has published list of Notified Bodies registered with CDSCO under MDR 2017. Medical Device Rules 2017 has...

Medical Devices-USA/Europe Regulatory News-September 2023

September 6, 2023
Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Artificial Intelligence in Drug Discovery and Development

September 6, 2023
Digital Health

The use of Artificial Intelligence (AI) in Medicinal Chemistry has gained significant attention in recent years as a potential means of revolutionizing the Pharmaceutical industry. Drug discovery,...

AI in Pharma, Drug Discovery, Future of Pharma, Medicinal Chemistry, Pharmaceuticals

Avoiding Common Pitfalls: Tips for Complying with FDA Cosmetics Regulations

August 25, 2023
Cosmetics

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into,...

Compliance Tips, Cosmetics Compliance, Cosmetics Regulations, FDA Compliance, FDA Regulations

Pharma Regulatory Intelligence Tools and Supply Chain Management

August 11, 2023
Biopharma

Many Organizations are relaying on the Regulatory Intelligence databases due to burden of collecting, understanding, interpretation of data from the regular authorities. Regulatory Intelligence tools...

Medical Devices-USA/Europe Regulatory News – August 2023

August 3, 2023
Medical Device

USA (FDA) Medical Device User Fee Rates for Fiscal Year 2024 The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees...

Europe Regulatory News, Harmonised standards, Medical Devices, Regulatory News, Software as a Medical Device (SaMD), USA Regulatory News