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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...[ Price : $8.95]
Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways...[ Price : $8.95]
FDA renews Certaras legacy licenses for its GlobalSubmit drug and biologics review software for another year.[ Price : $8.95]
Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or ef...