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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

Revised GMP guidelines for Pharma in India

Biopharma

The government recently directed all pharmaceutical companies in the country to implement the revised Biopharma The Indian government has recently mandated all pharmaceutical companies to adopt...

Drug Manufacturing, Global Compliance, Good Manufacturing Practices, Pharmaceutical Industry, Quality Control, Regulatory Updates

Consumer Health-USA and Asia Regulatory News-Sept 2023

Consumer Health

USA The U.S. Food and Drug Administration (FDA) Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products The U.S. Food and Drug Administration (FDA) is seeking...

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

The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

Digital Health

In order to distribute the products, pharmaceutical manufacturers must ensure compliancy with global and local regulations and provide the required testing and reporting to validate products, their...

Compliance Solutions, Drug Approval, Drug Registration, Regulatory Affairs, Regulatory Management, Regulatory Tracking Software

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

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

Artificial Intelligence in Drug Discovery and Development

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