PET RADIOPHARMACEUTICAL PREMARKET REQUIREMENTS TO BE DISCUSSED AT WORKSHOP; SYNCOR APPEALING UNSUCCESSFUL COURT CHALLENGE TO FDA PET REGULATIONS
This article was originally published in The Gray Sheet
Executive SummaryFDA premarket requirements for positron emission tomography radiopharmaceuticals are slated for discussion at a public workshop on April 28, the agency says in a March 14 Federal Register notice.
You may also be interested in...
Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.
India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.
Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.