Medical Writing Health Economics and Market Access Regulatory Writing Developments in paediatric regulation

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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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk