The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).
Following an inspection at the clinical site between 15 August 2016 and 14 September 2016, FDA says in the letter that Indianapolis-based Cassandra Curtis, MD, failed to adhere to the investigational plan’s protocol requiring certain subjects to be excluded and other requirements on the use of certain medications.
