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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration For a Business Headquartered Outside the United States 1. Name of business requesting MDUFA Small Business status FY 2013 MDUFA.

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I. Background Generic drug fee categoryFees rates for FY 2023GDUFA ProgramLarge size operation generic drug applicant1,620,556Medium size operation generic drug applicant648,222Small business operation generic drug applicant162,05611 more rows • 12 Oct 2022

FDA 2022 User Fee for Establishment Registration For FDA user fees 2022, the registration fee for each establishment is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups.

A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ing to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health.

What are user fees? The FDA collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.

Overall, the costs from beginning the application to obtaining an IDE can range from tens of thousands of dollars to even millions, but the average is ~$40,000.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232