PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for the product.
How much is a PDUFA fee?
FY 2020 and FY 2021 User Fee Rates:
| User Fee Type | 2020 | 2021 |
|---|---|---|
| Application Fee – Clinical Data Required | $2,942,965 | $2,875,842 |
| Application Fee – No Clinical Data Required | $1,471,483 | $1,437,921 |
| Program Fee | $325,424 | $336,432 |
How do you get pediatric exclusivity?
To qualify for pediatric exclusivity, the applicant must meet all of the following conditions:
- Be in receipt of a written request from FDA.
- Submit study reports after receipt of the written request.
- Meet the conditions of the written request.
What is FDA fee?
Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions.
What happens on a Pdufa date?
Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date. In some instances, the FDA grants Priority Review status to the regulatory filing for a drug.
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.
What comes first IND or NDA?
The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.
