FDA warns St. Louis, MO-based Vi-Jon about CGMP violations in its production of finished drugs.
Based on adverse events received, FDA sends Warning Letters to 12 companies for selling unapproved over-the-counter products intended to bleach or lig...
Two Arnall Golden Gregory attorneys recommend that drug companies keep all FDA promotion regulations in mind when they craft consumer and professional...
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...