GDF 2024 | D2S16 - ANDAs Labeling Requirements for Rx to OTC Switched Products

This presentation explained how prescription (Rx) drug products may initiate marketing status changes to over-the-counter (OTC) through the New Drug Application (NDA) process. The session discussed the process for labeling and policy updates when a Reference Listed Drug (RLD) undergoes an Rx-to-OTC switch. Roles of the Agency and Applicant were identified to clarify responsibilities during the transition process for generic drug applications.

Timestamps

01:46 – Overview

02:53 – Requirements for Full Switch and FDA Regulations

05:29 – Durham–Humphrey Amendment of 1951

07:42 – Pending and Approved Applications

11:12 – Division of Labeling Review (DLR)

13:50 – Summary

Speaker:

Bayli Larson, PharmD
Pharmacist
Patent and Exclusivity Team (PET)
Division of Legal & Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

Sunny Pyon
Labeling Project Manager
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
OGD | CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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