Dental procedures can be an ‘excellent models’ for sedation product evaluation.
Dental procedures can provide relevant efficacy and safety data as the Food and Drug Administration develops guidance on clinical development programs for sedation products, the ADA and four dental specialty organizations told the FDA.
“A dental perspective would be invaluable to the development of any clinical development program guidance,” the dental coalition said in response to FDA’s request for information related to the clinical development and use of sedation products in adult and pediatric age groups. Also commenting on the FDA plans were the American Academy of Pediatric Dentistry, American Academy of Periodontology, American Association of Oral and Maxillofacial Surgeons and American Society of Dentist Anesthesiologists.
