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CDER and the Critical Path Institute say they are launching an acute kidney injury project to develop prognostic tools.[ Price : $8.95]
FDA republishes OTC monograph user fees for FY 2021 to exclude some facilities producing hand sanitizer during the pandemic.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for CVRxs Barostim Neo, indicat...[ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that discuss the design...[ Price : $8.95]
Federal Register notice: FDA requests that any consumer organizations interested in participating in the selection of voting and n...[ Price : $8.95]
FDA clears a Rapid Medical 510(k) for its TigerTriever revascularization device for use in treating ischemic stroke.[ Price : $8.95]
EMD Serono suggests three topics for FDA consideration for an upcoming workshop on best practices for developing and applying dise...[ Price : $8.95]
FDA cautions Michael Levin for violations in his work as a clinical investigator for a clinical study.