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CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.[ Price : $8.95]
FDA asks members of two advisory committees for input on labeling options and communications strategies to address neuropsychiatri...[ Price : $8.95]
FDA approves a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and ...[ Price : $8.95]
FDA announces an Apotex recall of two strengths of generic Zantac labeled for Walgreens, Walmart, and Rite-Aid due to possible NDM...[ Price : $8.95]
Three Drinker Biddle attorneys caution drug companies to consult a recent FDA final guidance on REMS modifications and revisions t...[ Price : $8.95]
FDA clears a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings arti...[ Price : $8.95]
FDA approves an expanded indication for AbbVies hepatitis C drug Mavyret.[ Price : $8.95]
CDRH director Jeffrey Shuren says FDA would like to hear from companies if they would be comfortable having the agency make medica...