Regulatory Blog

The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...

Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...

The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...

Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based...

Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...

Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...

Last week (02 June 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research, Center for Drug...

Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...