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Federal Register Final rule: FDA approves an Intervet NADA for use of estriol tablets to control canine urinary incontinence.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, on Humanitarian Use Device designations.[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says an EUSA ProstaScint fact sheet fails to provide important information, overstates...[ Price : $8.95]
FDA tells Corcept Therapeutics that it will not require a Risk Evaluation and Mitigation Strategy program as part of its NDA submi...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says that a Sunovion sales representative made false or misleading statements about La...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says that a convention display booth for NeurogesX Qutenza failed to communicate risk ...[ Price : $8.95]
Gilead says it is seeking a new indication for Truvada for pre-exposure prophylaxis to prevent HIV-1 infection.[ Price : $8.95]
Attorney Kurt Karst says FDA is further clarifying its enforcement discretion policy for drugs being marketed pending a DESI deter...