FDA CDER’s Office of Nonprescription Drugs recently released its calendar of activities for monograph OTC products on September 30th. Planned activities largely surround GRASE status of active ingredients including codeine, oral benzocaine and/or phenol preparations, and ipecac. Additionally, the office will be reviewing PLLR labeling for NSAIDs; risks and benefits of cough/cold preparations for children under 6yrs; abuse/misuse risks of propylhexedrine; and labeling for single dose acetaminophen in pediatrics and children under 12yrs as well as determining whether labeling changes are required to account for skin allergies with acetaminophen-containing products. The Office also plans to address testing methods for anticavity products. These activities are proposed to be completed over the next 3 years. The full calendar is available here.
This recent publication is notable in that FDA CDER may eventually request safety data from companies that market the OTC monograph products targeted in 2023. Given that SafetyCall provides drug safety and pharmacovigilance services for your company we stand ready to assist you in addressing any such requests from FDA CDER. SafetyCall also provides a host of expert consulting services addressing product health and safety assessment, and routinely provides support for specific projects such as PLLR reviews.