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FDA publishes two lists of final and draft guidance topics for FY 2022 and a list of final guidances from four years for comment o...[ Price : $8.95]
Five drug companies comment on an FDA draft guidance on a cancer antibody treatment dosing regimen.[ Price : $8.95]
Novartis says further evaluation of its lung cancer treatment canakinumab is warranted even though a Phase 3 trial did not meet it...[ Price : $8.95]
CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides says FDAs need to conduct preapproval inspe...[ Price : $8.95]
Federal Register proposed order: FDA proposes to exempt certain blood and blood components for transfusion and cell and gene thera...[ Price : $8.95]
Washington Legal Foundation says the 9th Circuit Court of Appeals should uphold a lower court multi-district litigation decision t...[ Price : $8.95]
Sidley attorneys say a new FDA final rule expands the ways the agency determines whether a consumer product is intended for drug o...[ Price : $8.95]
The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies.