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USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA

Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.


Expanded access, often known as "compassionate use," is a potential pathway for a patient to obtain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no equivalent or satisfactory alternative therapy choices are available.

Concerning the execution of the legal specifications for expanded access, FDA got a lot of inquiries. As a result, this guidance provides information for the industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access to investigational drugs.


The main distinction between expanded access and the use of an investigational drug in the usual studies covered under an IND is that expanded access uses are not primarily intended to obtain information about the safety or effectiveness of a drug.


Click this LINK to know more about the Expanded access for treatment use, expanded access submission, etc.


Guidance: Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (OMUFA)


The term OTC monograph drug is a nonprescription, over-the-counter (or OTC) drug that may be marketed without an approved new drug application.


In short, this guide outlines the different OMUFA fee types, payment deadlines, and fee exclusions. This guideline also outlines how to pay FDA costs, what happens if you don't, how to get a refund, and how to challenge the way FDA assessed your OMUFA fees.


Click this LINK to know more about the Facility Fees, OTC monograph order request fees, Payment details etc.






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