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A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial design...[ Price : $8.95]
FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.[ Price : $8.95]
FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of...[ Price : $8.95]
AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.[ Price : $8.95]
Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleoge...[ Price : $8.95]
Former Pharmatech CEO Raidel Figueroa pleads guilty to conspiring to defraud FDA, among other charges, in a case involving contami...[ Price : $8.95]
FDA makes available a guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.