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Federal Register Notice: FDA seeks comments on a consulting firms assessment of the Prescription Drug User Fee Act Workload Adjust...[ Price : $8.95]
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Federal Register Notice: FDA releases a draft ICH guidance: M4E(R2): The CTD Efficacy.[ Price : $8.95]
Amicus Therapeutics delays its plans to submit an NDA by the end of the year for migalastat, indicated for treating Fabry disease,...[ Price : $8.95]
FDA grants RegenxBio an orphan drug designation for RGX-111 for treating mucopolysaccharidosis Type 1.[ Price : $8.95]
CDRH says Dupont Protection Technologies has demonstrated that its new (transition) Tyvek product is functionally equivalent to ex...[ Price : $8.95]
An ongoing House Energy and Commerce Committee investigation on management concerns at the NIH Clinical Center Pharmaceutical Deve...[ Price : $8.95]
FDA grants fast track designation to Xbiotech for its monoclonal antibody therapy for treating all forms of Staphylococcus aureus ...