The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, renews and strengthens the improvement of safety and effectiveness of paediatric drugs, biological products, and medical devices used in children.

It gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
It reauthorises two programs that have encouraged paediatric drug development and have provided funding to support a staff of trained reviewers who must determine whether a proposed new product is safe and effective for patients: the Prescription Drug User Fee Act (PDUFA), first enacted in 1992, and the Medical Device User Fee Act (MDUFA), first enacted in 2002.

In addition, FDASIA permanently reauthorizes the BPCA and the PREA, two laws providing procedures for paediatric drugs.
In details, according to the Best Pharmaceuticals for Children Act (BPCA) a 6-month period of marketing exclusivity for a drug is granted in return for the sponsor conducting FDA-requested studies in pediatric populations.

The Pediatric Research Equity Act (PREA) require pediatric studies when a sponsor submits an application for a modification of (a new indication, active ingredient, dosage form, dosing regimen or route of administration) an approved drug.
Until now, both laws had to be reauthorized every 5 years.
Finally FDASIA enacts several provisions intended to enhance the development of paediatric data.

The issuing of FDASIA confirms the interest of FDA in public health and innovation.

More information on FDA website.