[ Price : $8.95]
Consultant Russ King says that a new FDA guidance on 510(k) acceptance criteria shows the agencys increasing interest in medical d...[ Price : $8.95]
FDA again questions San Diego-based Pathway Genomics over a new direct-to-consumer genetic testing kit, this one targeting cancer.[ Price : $8.95]
Three stakeholders offer suggestions to improve an FDA draft guidance on weighing risk versus benefit in IDEs.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an interim study of the workload and costs associated with the review of biosimilar...[ Price : $8.95]
Sixty health and environmental groups ask Secretary of State John Kerry to urge FDA to conform with U.S. policy to reduce dental a...[ Price : $8.95]
Europes ECA Foundation praises an FDA draft guidance on quality metrics and raises some concerns.[ Price : $8.95]
CBER staffer Richard Forshee praises work done by the FDA Safety Graphics Working Group to apply good graphic design techniques to...[ Price : $8.95]
Amgen and Allergan say a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints.