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Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance...[ Price : $8.95]
FDA issues an updated question-and-answer draft guidance on expanded access to investigational drugs for treatment use.[ Price : $8.95]
A citizen petition asks FDA not to approve any Technetium-99m product produced through neutron capture in a conventional generator...[ Price : $8.95]
FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.[ Price : $8.95]
FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has i...[ Price : $8.95]
FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agenc...[ Price : $8.95]
Pfizer plans a year-end BLA for its investigational bivalent respiratory syncytial virus vaccine after stopping enrollment in a Ph...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection entitled Testing Communications by FDAs Center for Device...