Audio Transcript

For prescription and OTC drug products that require NDA approval, the first step we recommend is to conduct a thorough literature search for information regarding the ingredient(s) in your product. Once you have reviewed the literature and have adequate knowledge of the data you intend to support your application, request a Pre-Investigational New Drug, or IND, meeting with the appropriate review Division within OND, or ONP to discuss your proposed drug product and to get advice on your potential drug development program. An IND is required to be submitted to FDA prior to testing a drug in human subjects. The Guidance document titled, "Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products," will assist you in determining the type of meeting (e.g., Type A, Type B, Type C) to be requested.

Please make sure you review the Guidance document prior to sending a meeting request to ensure that all the necessary components are included, including a draft list of specific questions. An incomplete meeting request can cause a delay in the scheduling of your meeting or can result in denial of the meeting request.