Over-The-Counter (Otc) Drug Monograph Process

What is the Over-the-Counter (OTC) Drug Monograph Process?

OTC Monograph Reform Overview of Draft Guidance for Formal Meetings

U.S. Food and Drug Administration

OTC Monograph Reform: OMOR Format and Content & Electronic Submissions

U.S. Food and Drug Administration

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees

U.S. Food and Drug Administration

OTC Monograph Reform: Deemed Final Orders

U.S. Food and Drug Administration

OTC Monograph Reform: OTC Sunscreen Drugs

U.S. Food and Drug Administration

OTC Monograph Reform in the CARES Act: Safety Orders

U.S. Food and Drug Administration

Webinar Wednesday - Over the Counter OTC Drug Product Testing

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration

U.S. Food and Drug Administration

Monograph reform is here! Learn what to expect and how to prepare.

U.S. Food and Drug Administration

Modernizing FDA’s Regulationof Over-the-Counter Drugs

House Committee on Energy and Commerce

OTC Monograph Regulations Part 1 of 5

EAS Consulting Group

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration

U.S. Food and Drug Administration

Learn about Over-the-Counter (OTC) Pain Medications in 60 Seconds

Alliance for Aging Research

Over-the-counter Drug Application to FDA

(Review) Review of Over The Counter (OTC) Drugs - PMDA-ATC E-learning

FDA Wants To Make More Drugs Available OTC

Medicines In My Home: The Over-the-Counter Drug Facts Label

U.S. Food and Drug Administration

Introduction to GMP Standards for Over the Counter Drugs

NSF

OTC PSA (60s English)

Alliance for Aging Research