Tag: USA Regulatory News

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

Biopharma

EUROPEUS FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly is expected to assess the relationship between doses and/or...

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

Medical Devices-USA/Europe Regulatory News – Jan 2023

Medical Device

EUROPE MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 The guidance is applicable to medical devices which have been certified under...

Europe Regulatory News, Medical Devices, Regulatory News, USA Regulatory News

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