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US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or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

Medical Devices-Asia and ROW Regulatory News-Jan 2023

January 19, 2023
Medical Device

INDIA (CDSCO) Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer In order to...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Hong Kong Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices, Regulatory News, Saudi Arabia Regulatory News

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

January 18, 2023
Biopharma

Asia Malaysia Guide for ADR reporters NPRA published guide for ADR reporters which included improving the quality of reports, checklist for ADR reporters. Guideline also includes laboratory...

Armenia Regulatory News, Asia Regulatory News, Baharain Regulatory News, BioTech, India Regulatory News, Malaysia Regulatory News, Pakistan Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Tanzania Regulatory News

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

January 4, 2023
Biopharma

EU EMA recommendation paper: Safety, data integrity key to decentralized trial conduct The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently...

BioTech, Europe Regulatory News, Pharma, Regulatory Updates, US Regulatory News