[ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 11/17 on structured product labeling for the biologics industry.[ Price : $8.95]
FDA gives Enobia Pharma an orphan drug designation for ENB-0040, an enzyme replacement therapy for hypophosphatasia.[ Price : $8.95]
FDA approves GE Healthcares AdreView, a molecular imaging agent for detecting rare neuroendocrine tumors.[ Price : $8.95]
FDA orders a clinical hold on enrolling patients in a Stem Cell Therapeutics Corp. Phase 2b stroke trial called REGENESIS in Canad...[ Price : $8.95]
Ortho Biotech says preliminary study findings in Europe show a higher mortality rate when Procrit is given off-label to ischemic s...[ Price : $8.95]
Mallinckrodt says two pediatric leukemia cases have been reported in association with off-label intra-articular injection of its P...[ Price : $8.95]
Consulting editor John Scharmann reviews a new instance of CDRH management error in enforcement, compares it with others and concl...[ Price : $8.95]
CDER Drug Safety Oversight Board (DSOB) executive director Steven Osborne discusses the challenges it faces when deciding whether ...