What does QIDP stand for in FDA?
The purpose of this guidance is to provide sponsors a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP) under GAIN.
What is QIDP designation?
Definition: A US incentive scheme designed to promote the development of antibacterial and antifungal drugs to treat serious or life-threatening infections.
What is gain exclusivity?
The GAIN Act provides 5-year exclusivity extension on applications that have already received other exclusivities, such as new chemical entity (NCE) exclusivity for 5 years, orphan drug exclusivity (ODE) for 7 years, paediatric exclusivity for 6 months, etc3,4.
How do I apply for FDA fast track?
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.
What is the gain act?
To incentivize the creation of new treatments, the US Congress enacted the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012, which provides benefits to manufacturers of Qualified Infectious Disease Products (QIDPs) including 5 years of additional nonpatent exclusivity.
What is pediatric exclusivity?
Pediatric Exclusivity means exclusivity obtained in accordance with the requirements of Federal Food, Drug, and Cosmetic Act § 505a, 21 U.S.C. 355a. Pediatric Exclusivity means a Market Approval issued by FDA in application of 21 C.F.R. § 355a or its successor regulation.
How long does FDA fast track approval take?
within sixty days
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.
How long does FDA approval take?
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.
What is Type 3 DMF?
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
How long is a new drug patent good for?
Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.