General Information Regulatory

Draft Policy on Designating Regulators as Listed Authorities (WHO-Listed Authority) by WHO

The World Health Organization’s vision towards strengthening the regulation of medical products in underserved regions, the WHO published a draft policy on Designating Regulators as Listed Authorities (WHO-Listed Authority) to establish a framework for ensuring certain medical product regulators can be globally recognized as meeting WHO and other international standards and practices.

Regulatory

FDA Revised Draft Guidance on Drug Master Files

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Master Files.” Once finalized, this guidance will provide FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles […]

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