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Asia/ROW BioPharma Regulatory 2023 News/Updates recap

February 5, 2024
Biopharma

Asia China NMPA Tightens Regulation on Outsourced Manufacturing for MAHs NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing...

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

January 31, 2024
Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

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

December 7, 2023
Biopharma

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT),...

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News, Viral Safety Evaluation

Consumer Health-USA/Europe/Asia/ROW Regulatory News-Nov. 2023

December 7, 2023
Consumer Health

USA Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings The U.S. Food and Drug Administration published...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Cosmetic Labeling Requirements & Guidelines

December 4, 2023
Cosmetics

To ensure consumer safety, it is crucial for cosmetic manufacturers to be meticulous in labeling their products. With many cosmetic items being easily accessible without a prescription, it is important...