Dealing with Often-Confusing Pediatric Regulatory Requirements

Adult Medication Approval is Often Subject to Compliance with Pediatric Regulations. Let Us Guide You

We help ensure that you play by the rules. Scrupulously.

Current regulations for adult medication approvals in both the US and EU frequently require sponsors to make plans for pediatric studies; or, alternatively, they require that waivers be secured that would allow market approval to proceed without a pediatric component.

Although the pediatric regulations are well-intentioned, how to best accomplish pediatric trials is often as provocative a question for regulators as it is for industry sponsors.

Few sponsors are aware that regulatory requests for pediatric research often need to be reworked or revisited with Agency personnel. Premier Research can help demonstrate to regulators that the pediatric research requested needs to be amended to gain meaningful data or that alternatives to the requested work should be factored into a solution.

Premier Research also offers pharmacokinetic modeling services by which judicious data collection from a small sample of pediatric patients could mean the difference between satisfying and not satisfying regulatory requirements.

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