EPITOPE ORASURE PROMOTION CITED BY FDA IN WARNING LETTER
This article was originally published in The Gray Sheet
Executive SummaryEPITOPE ORASURE PROMOTION CITED BY FDA IN WARNING LETTER, the Beaverton, Oregon-based company reports. In a Dec. 19 press release, the company said that the Dec. 14 warning letter objects to performance claims about the unapproved HIV-1 oral specimen collection device that were included in company-prepared materials for a scientific presentation made last June.
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.