Name that Term
A non-prescription drug that is safe and effective to use by the general public without an HCP’s prescription
What is an over-the-Counter (OTC) Drug?
Name the drug that is linked to severe birth defects, including limb deformities, when taken during pregnancy and has paved the pathway to drug regulation
What is Thalidomide?
New Drug Application (NDA) OR OTC Monograph:
Product specific (including formulation)
What is NDA?
Name one way the OTC Monograph has been reformed
Any one of these works:
What is...
•Administrative Order Process
•Status of Final Monograph Regulations
•Status of Existing OTC Monograph Products
•Minor Changes in Dosage Form
•Exclusivity
•Treatment of Sunscreen Innovation Act
•User Fees (OMUFA)
•Formal Meetings with FDA
•Confidential Information
•OTC Monograph Reform Required Guidance
Rather than reviewing hundreds of thousands of individual OTC products, the FDA created monographs that established what kind of guidelines to ensure the safety and efficacy of OTC drugs
What is called Generally Recognized As Safe and Effective (GRASE)?
Name the two pathways to market OTC drugs
What is an NDA and OTC Monograph?
New Drug Application (NDA) OR OTC Monograph:
Public process - no data confidentiality
What is OTC Monograph?
What two parties can initiate an Administrative Order?
Who are the FDA or sponsor (industry)?
This modernized the OTC drug review and OTC monograph drug development process and provided the FDA with the authority to collect user fees dedicated to OTC monograph drug activities
What is the CARES Act?
True or false:
Sunscreen is a therapeutic category approved via an OTC monograph
What is true?
New Drug Application (NDA) OR OTC Monograph:
Ingredient and therapeutic category specific regulations (CFR 330-358)
What is OTC Monograph?
Name one fee that has been established in the OTC User Fee Program
What is the facility fee?
What is the OTC Monograph Order Request (OMOR) fee?
This replaces the 3-phase rulemaking process by allowing the FDA to add, remove, or make changes to GRASE conditions for an OTC drug monograph
What is an Administrative Order?
Name at least one phase of the 3-phase rulemaking process to establish OTC monographs
What is:
1. Advance Notice of Proposed Rulemaking (ANPR)
2. Tentative Final Monograph (TFM)
3. Final Monograph (FM)
New Drug Application (NDA) OR OTC Monograph:
Comply with good manufacturing practices
What is both?
The location of the FDA's final orders for an OTC Monograph
What is the FDA's public website (OTC Monographs@FDA)