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Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements.

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The first of the fast tracks opened in 1988. This track emphasises early communication between the FDA and the drug company. It enables companies to have a 'rolling review' of their drugs. The companies submit information as it becomes available, rather than submitting data after all the clinical trials are completed.

To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met.

Qualifying Criteria for Designation. Show superior effectiveness on serious outcomes or improved effect on serious outcomes. Provide an alternative for patients not eligible or patients refractory to available treatments. Show an improved safety profile compared to available treatments.

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Fast Track designation allows the manufacturer or drug developer to meet and communicate more frequently with the FDA. To receive Fast Track designation, the drug developer must apply for the designation. At this point, the FDA will review and deliver a decision on the designation within 60 days.

The Fast Track Designation process helps to facilitate the development and expedite the review of new drugs that treat a serious medical condition and fill an unmet medical need. By speeding up these processes, new drugs can get to patients in need faster than they normally would through standard tracks.

11 drugs granted FDA fast track designation in 2022.

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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
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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:
+1 833 426 79 33
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