Tag: USA Regulatory News

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US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or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 – Jan 2023

January 4, 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

December 8, 2022
Medical Device

EUROPE 1. Updated information pack for candidate EU reference laboratories publishedRegulation (EU) 2017/746 empowers the European Commission to designate one or more EU reference laboratories for...

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