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Federal Register notice: FDA makes available a final guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Ad...[ Price : $8.95]
An FDA complete response letter says a Spero Therapeutics NDA for tebipenem HBr tablets to treat adults with complicated urinary t...[ Price : $8.95]
FDA warns Irving, TX-based Re-Gen Active Lab about multiple violations in its production and marketing of several cellular-based d...[ Price : $8.95]
FDA warns St. Paul, MN-based Fagron Group about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms ...[ Price : $8.95]
FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional conditio...[ Price : $8.95]
Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemen...