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

February 21, 2023
Biopharma

Asia India WHO calls for action after Asia-made medicines linked to 300 deaths Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough...

Asia Regulatory News, Australia Regulatory News, BioTech, India Regulatory News, Japan Regulatory News, Malayasia Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Singapore Regulatory News

Medical Devices-Asia and ROW Regulatory News-Feb 2023

February 16, 2023
Medical Device

CHINA (CFMDE-NMPA) Announcement of the State Food and Drug Administration on Issuing YY/T 1888-2023 “Recombinant Humanized Collagen” Medical Device Industry Standard (2023 No. 14) The...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Malayasia Regulatory News, Medical Devices, Panama Regulatory News, Philippines Regulatory News, Regulatory News, Saudi Arabia Regulatory News

Medical Device Labelling Requirements

February 13, 2023
Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Informative, accurate labeling is required, and every label included with the device has to meet the applicable...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA

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

February 3, 2023
Biopharma

US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response...

BioTech, Biotech Regulatory News, EU Regulatory News, Pharma, Pharma Regulatory News, Regulatory Updates, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-Feb 2023

February 2, 2023
Medical Device

USA (FDA) Surveying, Leveling, and Alignment Laser Products – Guidance for Industry and Food and Drug Administration Staff The guidance is intended to summarize FDA’s current thinking on...

Regulatory reporting software

January 31, 2023
Standards

Regulatory reporting software helps in collecting data from systems of companies and produces regulatory reports by industry regulations. A regulatory reporting system helps in managing and automating...

Artificial Intelligence, Case Safety Reports, clinical research, health authority documents, manufacturing, quality, R&D, Regulatory Reporting, Regulatory reporting software, regulatory reports, Safety reports