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

March 21, 2023
Biopharma

Pakistan Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update...

Medical Devices – Asia and ROW Regulatory News – March 2023

March 21, 2023
Medical Device

JAPAN (PMDA) Medical safety measures related to pharmaceuticals and medical devices The Ministry of Health, Labor and Welfare is promoting various efforts to prevent medical accidents, but it...

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

Maximizing Success and Mitigating Risk: The Strategic Role of Pharma Regulatory Intelligence Database in the Pharmaceutical Industry

March 14, 2023
Biopharma

Regulatory intelligence refers to the process of gathering and analyzing information about the regulatory landscape, including laws, policies, and guidelines, that may affect a particular industry....

Drug Development, Mitigating Risk, Pharma Regulatory Intelligence, Regulatory Affairs, Regulatory Intelligence, Regulatory Intelligence Database

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

March 7, 2023
Biopharma

US FDA Offers Advice on Macular Degeneration Drug Trials The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance....

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – March 2023

March 2, 2023
Medical Device

USA (US FDA) Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff The guidance...

Canada Regulatory News, Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

Medical Device and Restricted Hazardous Substances

February 28, 2023
Medical Device

RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated...

Medical Device, Restricted Hazardous Substances, RoHS, RoHS Certification, RoHS Testing