How does pediatric exclusivity work?

Pediatric exclusivity does not accrue only to the product that was studied in the pediatric population. It attaches to all the applicant’s formulations, dosage forms, and indications for products with existing marketing exclusivity or patent life that contain the same active moiety.

How does FDA define pediatric?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment.

What is FDA exclusivity?

Exclusivity: is granted for a drug product by the FDA upon approval that affects the timing of. submission and/or approval of certain other applications and may run concurrently with a patent but does not need to do so.

What is FDA written request?

Description of FDA’s Written Request A Written Request is a specific document from FDA that is signed by the applicable office director(s) in which the Agency requests submission of certain studies to determine if the use of a drug could have meaningful health benefits in the pediatric population.

What is the difference between patent and exclusivity?

Patents and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met.

Is 19 considered pediatric?

With few exceptions, patients 18 years and older should be admitted to an adult service and patients less than 18 years should be admitted to a pediatric service.

What is difference between patent and exclusivity?

What is written request?

Written Request means a writing that asks for information, and includes a writing transmitted by facsimile, electronic mail, or other electronic means.

What is a proposed pediatric study request?

A Written Request (WR) is a legal document laying out the conditions under which a pediatric clinical trial should be conducted. In turn, the Written Request has the benefit for the sponsor of extending the marketing exclusivity of a drug before expiry of patent protection.

Does FDA approval mean anything?

The approval, says the FDA, means “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”