Table of Contents
What is monograph reform?
About OTC Monograph Reform Specifically, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. The CARES Act also provides FDA the authority to assess and collect user fees dedicated to OTC monograph drug activities.
Are OTC FDA approved?
FDA regulations ensure that OTC drugs are safe and that the labels are easy to understand. OTC drugs can be bought and used safely without the need for a prescription. All OTC drug products have to meet FDA quality, effectiveness, and safety standards.
What is a monograph drug facility?
As defined in the statute, an OTC monograph drug facility means a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.
What is OTC device?
Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these devices do not require a prescription for sale. Some examples of OTC medical devices include bandages, menstrual products, and condoms.
What is a monograph OTC?
An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …
What is the Omufa fee?
OMUFA fees will support FDA’s OTC monograph drug activities, which are detailed in section 744L(6) of the FD&C Act and include various FDA activities associated with OTC monograph drugs and inspection of facilities associated with such products.
Is a monograph an article?
It’s a distinction based on length and scope. (Monographs and novellas are probably harder to get published than their more common kin.) Looking into that journal’s submission policies, it appears that articles have a word limit while monographs do not.
How can I find a monograph?
Scholarly monographs are typically purchased by academic and research libraries for use by scholars, including students. You won’t usually find them on bookstore shelves.
Do you need a prescription for a medical device?
Not all medical devices require a prescription; however, many medical devices do require a prescription (for example, contact lenses).