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CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.[ Price : $8.95]
FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of th...[ Price : $8.95]
Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeS...[ Price : $8.95]
OncoSec says its Tavo-EP in combination with Mercks Keytruda failed to meet the overall response rate primary endpoint in a Phase ...[ Price : $8.95]
FDA warns Fullerton, CA-based Synovo Production about its manufacturing and distribution of adulterated and misbranded orthopedic ...[ Price : $8.95]
Lilly researchers say FDA was consistent in meeting its mid-cycle communication goals under a 2012 program to educate regulatory p...[ Price : $8.95]
FDA approves an emergency use authorization for InflaRxs Gohibic to treat some hospitalized Covid-19 patients.[ Price : $8.95]
FDA clears a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray.