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The Generic Pharmaceutical Association disagrees with FDA, PhRMA, and BIO on the need for a separate biosimilars user fee program.[ Price : $8.95]
CDER drug reviewers recommend not to approve a Janssen Pharmaceuticals NDA for its investigational drug Xarelto (rivaroxaban), whi...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Creations Garden Natural Products, Edelweiss Farms, Facet Technologies, Lehigh V...[ Price : $8.95]
Ohio State University researchers say they found a higher risk of drug manufacturing quality problems in Puerto Rican facilities o...[ Price : $8.95]
Federal Register Notice: FDA corrects an address in an 8/12 Federal Register notice announcing a workshop on a mobile medical appl...[ Price : $8.95]
Leo Pharma asks FDA to require applicants for generic Dovonex to perform specific tests before their ANDA can be approved.[ Price : $8.95]
FDA announces two new staff training programs for medical device reviewers that it says will improve their consistency.