In response to the Food and Drug Administration’s request for information regarding the clinical development and use of sedation products in adult and pediatric age groups, the American Dental Association and four dental specialty organizations responded that dental procedures can provide meaningful data on the safety and capability of sedation products. “A dental perspective would be invaluable to the development of any clinical development program guidance. Dental surgical/restorative procedures are excellent models for the use of sedation drug products and their evaluation,” the dental coalition says in a July 3 letter to the FDA. “Meaningful safety data come from both healthy patients and those who are more susceptible to respiratory complications, particularly children and adolescents.” Joining the ADA in the coalition were the American Academy of Pediatric Dentistry, American Academy of Periodontology, American Association of Oral and Maxillofacial Surgeons and American Society of Dentist Anesthesiologists. The FDA request states that: “The Food and Drug Administration (FDA) is seeking information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups. FDA is inviting any interested party, or parties, to facilitate an evaluation of critical fundamentals of the science related to sedation products by conducting and managing a coordination of activities that will bring together experts in the field, including from academia, patient organizations, and industry.” The coalition explains how crucial the safety and reliability of sedation products is in the dental profession. “Safe and effective sedation products are a critical part of oral health care, especially for patients with special needs and those who suffer from anxiety associated with dental or other medical procedures and conditions,” the coalition reports. “We urge you to include dental representatives on any future panels or workgroups that may aid in drafting of industry guidance on the clinical development and use of sedation products in adult and pediatric age groups.” View the cover letter and comments here.
