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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

Understanding FDA Labeling Regulations

October 18, 2023
OTC

All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. FDA holds that labeling encompasses: Any written, printed...

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

Role of Technology in Regulatory Intelligence

October 12, 2023
Digital Health

Introduction to Regulatory Intelligence Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines...

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

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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...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

Medical Devices-USA/Europe Regulatory News-October 2023

October 5, 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 preparation...

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

Revised GMP guidelines for Pharma in India

September 26, 2023
Biopharma

The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards. Larger...

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