Pediatric Research Equity Act (Dec, 2003) requires pediatric studies of certain drugs and biological products unless waived or deferred. The law mandates a pediatric assessment for applications with new ingredients, new indications, new dosage forms, new dosing regimens or new routes administration. PREA also requires that the studies must be designed to pose minimal risks and direct benefit. For a course of disease or effect similar to adults, effects can be extrapolated from the studies conducted in adults. To read more about the PREA, click here.
Create a mindful journey of life with practice, giving and be able to say a 'no' when it matters!