FDA says the Elgin-IL-based Regenerative Stem Cell Institute is marketing cellular products without an approved BLA or IND.
Three Morrison Foerster attorneys say a recent Connecticut federal court decision in a case involving Mercks Gardasil demonstrates there is a high bar...
Harvard Medical School researchers say FDA should clearly indicate when it has extrapolated an approved drug indication from pivotal trial data.
CDER says it doesnt object to additional materials Covis Pharma wants to introduce at a hearing on the FDA proposal to withdraw approval for Makena bu...
FDA cautions that noninvasive prenatal screening tests can give false results that can lead to inappropriate decisions without a confirmatory diagnost...
FDA reiterates concerns with phosphatidylinositol 3-kinase (PI3K) inhibitors and their approval for treating hematological malignancies.
FDA warns the Norcross, GA-based Center for Rare Neurological Diseases about human subject protection violations in its conduct of two clinical trials...
Federal Register notice: FDA makes available a draft guidance for industry #106 entitled The Use of Published Literature in Support of New Animal Drug...