[ 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Three stakeholders offer suggestions to improve an FDA draft guidance on weighing risk versus benefit in IDEs.[ Price : $8.95]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]
Europes ECA Foundation praises an FDA draft guidance on quality metrics and raises some concerns.[ Price : $8.95]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.[ Price : $8.95]
FDA clears a Zeltiq Aesthetics 510(k) to allow the use of its CoolMini applicator with the CoolSculpting device to treat smaller p...[ Price : $8.95]
Perkins Coie attorneys caution drug and medical device companies not to read too much into a federal court decision backing a drug...[ Price : $8.95]
A stakeholder dialog sponsored by the National Health Council and Genetic Alliance identifies barriers to improving patient engage...