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  • Comparison Of Psp And Pip What's In A Form? - Fda

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Global Pediatric Development: Comparison of PSP and PIP. Hari Cheryl Sachs, M.D.. Team Leader, Pediatric and. Maternal Health Staff .

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A Pediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) is a development plan intended to support the authorization of a medicine for children by ensuring data are obtained through studies in the paediatric population during clinical trials.

PREA: Is triggered by an application for a new indication, new dosage form, a new dosing regimen, a new route of administration or a new active ingredient. Authorizes FDA to require a pediatric assessment of some approved drug/biologic products for certain indications.

A request made to FDA by a drug sponsor, leading to the issue of a Written Request by FDA. A Written Request (WR) is a legal document laying out the conditions under which a pediatric clinical trial should be conducted.

Information For Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring.

Pediatric Study Plan (PSP): An outline of the pediatric study or studies that the sponsor plans to conduct (including, to the extent practicable, study objectives and design, age groups, relevant endpoints, and statistical approach); any Page 6 of 15 Page 7 Center for Biologics Evaluation and Research SOPP 8421 request ...

A pediatric investigation plan (PIP, required in the European Union) or pediatric study plan (PSP, required in the United States) is a development plan aimed at ensuring that the necessary data are obtained through clinical trials in the pediatric population.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232