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FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unappr...[ Price : $8.95]
FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.[ Price : $8.95]
FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynth...[ Price : $8.95]
FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (f...[ Price : $8.95]
Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.[ Price : $8.95]
The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-rep...[ Price : $8.95]
FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could re...