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

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

Biopharma – Europe, USA and Asia Regulatory News, Dec 2022

Biopharma

EU ICH M12 on drug interaction studies – Scientific guideline This guideline offers recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated...

Global Regulatory Intelligence

Standards

The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes keep evolving and vary across markets. Establishing an effective regulatory...

Clinical Trials, Compliance Procedures, Health Authority, Manufacturing Requirements, Regulatory Intelligence

Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

Medical Device

EUROPE 1. Updated Information Pack for Candidate EU Reference Laboratories Regulation (EU) 2017/746 authorizes the European Commission to designate EU reference laboratories for specific devices...

Canada Regulatory News, Europe Regulatory News, Ireland Regulatory News, Medical Devices News, UK Regulatory News, USA Regulatory News

EU MDR Regulations

Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of Act (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR

Artificial Intelligence Based Regulatory Intelligence database

Digital Health

VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health...

Artificial Intelligence, BioPharma, Consumer Health, Diagnostics, Digital Health, Medical Devices, OTC, Regulatory Intelligence