Module 1 2021

Where to submit IND?

CDER Office of New Drugs

- Office of Antimicrobial Products (OAP) - Office of Drug Evaluation I Division of Cardiovascular and Renal Products (DCaRP)

Division of Neurology Products (DNP) Division of Psychiatry Products (DPP)

- Office of Drug Evaluation II Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) Division of Metabolism and Endocrinology Products (DMEP) Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) - Office of Drug Evaluation III Division of Dermatology and Dental Products Division of Gastroenterology and Inborn Errors Products Division of Reproductive and Urologic Products - Office of Drug Evaluation IV Division of Medical Imaging Products Radioactive Drug Research Committee (RDRC) Program - Office of Hematology and Oncology Drug Products

51

Types of FDA Meetings • Type A:

– A critical path meeting (eg. Clinical Hold issue) • Type B: – Pre-IND meetings, certain End of Phase 1, meetings, End of Phase 2 / pre-Phase 3 meetings, and pre-NDA / BLA meetings • Type C: – Any meetings other than a Type A or Type B meeting

–

Note: no charge to FDA Draft guidance formal FDA meetings: https://www.fda.gov/media/109951/download

52

52

26