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Federal Register Notice: FDA releases a new guidance: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination...[ Price : $8.95]
CBER says a Canadian Web site is illegally promoting unapproved at-home HIV tests for sale in the U.S.[ Price : $8.95]
FDA says that generic bioequivalence determinations are not impacted by recent concerns raised by a scientific article that questi...[ Price : $8.95]
FDA approves a Navidea Biopharmaceuticals supplemental NDA for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) inje...[ Price : $8.95]
FDA accepts for priority review an Eisai NDA for its in-house developed anticancer agent lenvatinib mesylate as a treatment for pr...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection on the labeling of natural rubber latex condoms.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on distinguishing device recalls from medical device enhancements.[ Price : $8.95]
FDA approves two NDAs ahead of their user fee goal dates for treating idiopathic pulmonary fibrosis.