The shelf-life of a drug product is the time that the average drug characteristic (e.g., potency) remains within an approved specification after manufacture. The United States Food and Drug Administration (FDA) requires indication for every drug product of a shelf-life on the immediate container label. Since the true shelf-life of a drug product is typically unknown, it has to be estimated base...

BACKGROUND Clinical practice guidelines (CPGs) recommend pharmacologic treatments for clinical conditions, and drug structured product labels (SPLs) summarize approved treatment indications. Both resources are intended to promote evidence-based medical practices and guide clinicians' prescribing decisions. However, it is unclear how well CPG recommendations about pharmacologic therapies match S...

Prior to commercial distribution of any new animal drug for use in food-producing animals, a sponsor must prove its product is safe and effective when used as described in the proposed labeling of the drug. Effectiveness simply means that the product does what the labeling claims. Safety routinely covers the safety of the food products to humans, and safety to the target animals. In addition to...