Following this puts new work involving it at the top of your briefing, with a note saying why it is there. Links are taken from the source record, never inferred.
Phase 1 study of a novel gastrointestinal agent in a small, healthy volunteer population with pharmacokinetic endpoints; no efficacy or safety results reported in this registry record.
This is an FDA supplemental approval action establishing a Risk Evaluation and Mitigation Strategy (REMS) for a combination opioid-analgesic product; it documents a regulatory decision, not clinical evidence of efficacy or safety.
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing oxycodone–acetaminophen combination product; this is a regulatory action, not a clinical evidence assessment.
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for hydrocodone bitartrate and acetaminophen combination tablets across four dosage strengths.
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing opioid-acetaminophen combination product; this is a regulatory action, not a clinical trial.
FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) for an acetaminophen–codeine combination oral solution; regulatory action that affects product labelling and use conditions, not a clinical evidence assessment.
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing oxycodone-acetaminophen combination product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.
FDA supplemental approval action for an existing opioid–acetaminophen combination product; regulatory record documenting REMS requirement but not clinical efficacy or safety trial data.