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FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...[ Price : $8.95]
Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...[ Price : $8.95]
Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.[ Price : $8.95]
Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics sup...[ Price : $8.95]
A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signali...[ Price : $8.95]
Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Pr...[ Price : $8.95]
Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any d...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufac...