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FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapa...[ Price : $8.95]
FDA announces a 12/7 public workshop on Appropriate Use of Consensus Standards to obtain public input on using these in premarket ...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facili...[ Price : $8.95]
Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.[ Price : $8.95]
AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous conce...[ Price : $8.95]
FDA issues Roche Molecular Systems an emergency use authorization for its cobas MPXV monkeypox test.[ Price : $8.95]
ECA Academy lists the top 10 GMP observations from 42 Warning Letters issued in FY 2022.[ Price : $8.95]
Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import an...