FDA | ARQon

6 days ago2 min read

Thailand: Guidelines for Document Referencing, Transfers, & Compliance in Medical Device Applications (w.e.f. 20 September 2024)

In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or...

Oct 292 min read

US: FDA’s DSCSA Exemptions, Waiver, & Exception

FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...

Sep 113 min read

Philippines: DOH Guidelines for the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Exclusively for Export

On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for...