Assessing user fees under the prescription drug user fee amendments of 2017
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval Prescription Drugs United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance provides stakeholders information regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017. Because PDUFA VI created changes to the user fee program, this guidance explains the new fee structure created by the statute, and the types of fees for which entities are responsible. This guidance describes the types of user fees authorized by PDUFA VI, the process for submitting payments to FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process for requesting a reconsideration of a user fee assessment. The guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. FDA has separate guidance documents about PDUFA VI waivers, refunds, and reductions. This guidance does not address how FDA determines and adjusts fees each fiscal year (FY); nor does it address FDA’s implementation of other user fee programs (e.g., Biosimilar User Fee Amendments, Generic Drug User Fee Amendments). Throughout this guidance, references to user fees or the user-fee program are to prescription drug user fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (14 pages)).
- NLM Unique ID:
- 9918249008506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918249008506676