Author: admin

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

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

August 3, 2023
Biopharma

US FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees Increase While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar...

Biotech Regulatory News, EU Regulatory News, marketing authorization, Pharma Regulatory News, post marketing requirements, Regulatory News, USA Regulatory News

Pharma/Biotech – Asia, ROW Regulatory News, July 2023 Vol. 2

July 26, 2023
Biopharma

ASIA Singapore Guidance on therapeutic product registration in Singapore This guidance document describes the procedures and requirements for submitting an application to register a therapeutic...

Asia Regulatory News, BioTech, New Molecular Entities, Pharma, Regulatory Updates, ROW Regulatory News, Swissmedic, Therapautic Product