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Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapti...[ Price : $8.95]
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.[ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequ...[ Price : $8.95]
FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up t...[ Price : $8.95]
International Contrast Ultrasound Society petitions FDA to remove Boxed Warnings from ultrasound contrast agents.[ Price : $8.95]
FDA approves Medtronics MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically mon...[ Price : $8.95]
FDA grants Baxter International a de novo application for the Theranova dialysis membrane.[ Price : $8.95]
FDA commissioner Stephen Hahn says it is possible that an emergency use authorization for a Covid-19 vaccine could be granted befo...