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A North America Free Trade Agreement tribunal sides with FDA by rejecting the companys claims that the agency violated NAFTA by pr...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Ad-Med Biotechnology, LLC A.M.S. Bioteck, Big Easy Confections, Calaire Chimie, ...[ Price : $8.95]
CDER posts an online training course entitled Human Drug Establishment Registration and Drug Listing Compliance.[ Price : $8.95]
Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/8-9 to discuss a Boston Scientific PMA for its Watchma...[ Price : $8.95]
Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/6 to discuss a guidance on virus...[ Price : $8.95]
Federal Register Final rule: FDA amends the medical device regulations to correct minor errors.[ Price : $8.95]
A new CDER policy document outlines procedures for informing NDA/BLA applicants about planned review timelines, including goal dat...[ Price : $8.95]
Alkermes files an NDA for aripiprazole lauroxil, a once-monthly, long-acting injectable atypical antipsychotic for treating schizo...