Effective procurement is not merely about finding the lowest-cost materials; it requires a clear communication channel ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
The FDA will begin accepting applications Feb. 1 for its PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain. The program aims to increase regulatory ...
U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...
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