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Federal Register: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on ...[ Price : $8.95]
FDA posts a guidance entitled: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that describes the agencys curre...[ Price : $8.95]
Four congressional Democrats introduce a bill to require HHS to negotiate prices for Medicare Part D covered drugs.[ Price : $8.95]
FDA clears a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with c...[ Price : $8.95]
FDA approves a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preven...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Devi...[ Price : $8.95]
Achaogen files an NDA for plazomicin, indicated for treating complicated urinary tract infections.[ Price : $8.95]
Amneal Pharmaceuticals says FDA should not approve any ANDA citing its Forteo as the reference-listed drug that does not contain r...