What is drug designation?
When a drug is designated for a particular intended use, the sponsor of the drug obtains seven (7) years of exclusive marketing rights upon approval (or conditional approval) of the drug for that intended use.
What is FDA breakthrough status?
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
How do I get a 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.
How much faster is FDA fast track?
According to a 2017 document by FDA officials, the traditional drug development process can take 9.5 to 14 years; expedited drugs can take 5.5. to 11 years.
What is the benefit of orphan drug designation?
Orphan drug status gives companies exclusive marketing, and development rights along with other benefits to recoup the costs of researching and developing drugs to treat rare diseases. The Orphan Drug Act was designed to encourage companies to develop drugs for rare diseases.
Can you lose orphan drug designation?
(c) Where a drug has been designated as an orphan drug because the prevalence of a disease or condition (or, in the case of vaccines, diagnostic drugs, or preventive drugs, the target population) is under 200,000 in the United States at the time of designation, its designation will not be revoked on the ground that the …
What does Breakthrough Therapy designation really mean for?
Just the name of the designation alone suggests that the FDA has all but stamped the drug with a guarantee of approval. In fact, the agency has come under some fire for this, since it makes the FDA seem less impartial a judge of the merits of the drug.
How to request a breakthrough device designation from the FDA?
How to request a Breakthrough Devices Designation. You can request the Breakthrough Device designation by submitting a “Designation Request for Breakthrough Device” Q-Submission. Your designation request should be the only request in the Q-Submission.
What makes a drug a breakthrough therapy fast track?
A breakthrough therapy/fast track designation applies to a combination of a drug (either alone or in combination with other drugs) and the specific use for which it is being studied.
What do you mean by breakthrough devices program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.