Tag: FDA

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

July 12, 2023
Biopharma

USA No Big-Picture Impact for Manufacturers in CMS IRA Updates In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price...

Biotech Regulatory News, EMA, EU Regulatory News, FDA, GCP Guideline, MHRA, Pharma Regulatory News, Regulatory News, RWD, RWE, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News

Medical Devices – USA, Europe, Asia Regulatory News – Nov 2022

November 30, 2022
Medical Device

Asia Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration with Approval by The NRA of Any ASEAN Member Country Philippines FDA issues Circular No. 2022-008...

Asia, Devices, Europe, FDA, HSA, IVDR, Liver Cancer, MDCG, Regulatory News, South Africa, USA