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FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter d...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.[ Price : $8.95]
FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consist...[ Price : $8.95]
FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.[ Price : $8.95]
Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party la...[ Price : $8.95]
During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no l...[ Price : $8.95]
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven pep...[ Price : $8.95]
FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in pl...