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

August 3, 2023
Biopharma

US FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees Increase While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar...

Biotech Regulatory News, EU Regulatory News, marketing authorization, Pharma Regulatory News, post marketing requirements, Regulatory News, USA Regulatory News

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

July 26, 2023
Biopharma

ASIA Singapore Guidance on therapeutic product registration in Singapore This guidance document describes the procedures and requirements for submitting an application to register a therapeutic...

Asia Regulatory News, BioTech, New Molecular Entities, Pharma, Regulatory Updates, ROW Regulatory News, Swissmedic, Therapautic Product

Medical Devices-Asia and ROW Regulatory News-July 2023

July 25, 2023
Medical Device

ASIA SINGAPORE (HSA) HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD) An SRA is a national health products regulatory authority considered by the WHO to apply stringent...

Asia Regulatory News, IVD, Medical Devices, Regulatory News, ROW Regulatory News

Regulatory Intelligence shows path to the Success in Pharma Industry

July 21, 2023
Biopharma

Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market. Companies have to analyze, monitor and gather the information...

Compliance, Healthcare, Medical Devices, Pharma Industry, Regulatory Intelligence, Regulatory Updates

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