[ Price : $8.95]
FDA issues a guidance with concepts for sponsors and stakeholders to consider when choosing to collect and submit patient preferen...[ Price : $8.95]
FDA proposes regulatory changes to implement a Good Laboratory Practice Quality System to help ensure the quality and integrity of...[ Price : $8.95]
FDAs Cincinnati District Office warns Tosoh Bioscience about multiple Quality System regulation violations at its Grove City, OH, ...[ Price : $8.95]
Stakeholders voice general support for a PDUFA 6 commitment letter circulated by FDA for comments.[ Price : $8.95]
FDA grants Vaccinex an orphan drug designation for its therapeutic monoclonal antibody VX15, which is currently being investigated...[ Price : $8.95]
FDA posts a final guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and...[ Price : $8.95]
FDA accepts for priority review a Clovis Oncology NDA seeking accelerated approval for rucaparib and its use in treating certain a...[ Price : $8.95]
Lilly asks FDA to reject ANDAs for its Forteo and ultimately treat it as a biological product after revising the regulatory defini...