Medical Writing Health Economics and Market Access Regulatory Writing Developments in paediatric regulation
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Volume 22, Issue 3 - Health Economics and Market Access

Regulatory Writing Developments in paediatric regulation

Abstract

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and inconsistencies regarding the PIP document. In the USA, the Food and Drug Administration Safety and Innovations Act (FDASIA) has effectively made it mandatory to submit a paediatric study plan (PSP, the US equivalent of a PIP) soon after completion of phase II of development. Drug companies will need to work out how best to manage having two approved plans in parallel and avoid discrepancies.

References

  1. The PIP template Available from: http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000293.jsp&mid=WC0b01ac0580025b91
  2. Food and Drug Administration Safety and Innovations Act (FDASIA) information. Available from: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/
  3. The PSP template Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM338453.pdf
  4. Guidance for Industry: How to comply with the Pediatric Research Equity Act, September 2005. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077855.pdf

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