December 2003
The Pediatric Research Equity Act (PREA) was signed into law on December 2003 and reauthorized in 2007 and 2012. PREA mandates paediatric studies for new drugs or biologics which are required only on adult indication (s) under review.
What is PREA in Drug development?
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.
What is the pediatric Final Rule?
In late 1998, FDA published regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients – known as the Pediatric Rule. FDA recommended that sponsors submit the proposed timeline at least 1 month before the end-of-phase 2 meeting.
What is the pediatric rule?
The Pediatric Rule requires drug manufacturers to study the efficacy and safety of their products in children or risk denial of FDA approval. The Rule also requires manufacturers to devise formulations of drugs for use in children.
What do the pediatric rule states?
For currently marketed drugs and biological products, the rule authorizes FDA to require pediatric studies if (1) they are used for a labeled indication in a substantial number of pediatric patients (defined as 50,000 or more) and the absence of adequate labeling could pose a significant risk to pediatric patients, or …
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 |
