Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules

$397.00
Quantity Discounts
1 - 2
$397.00
3 - 4
$357.00
5 - 6
$337.00
7 - 9
$317.00
10 - 9999
$297.00

Adding Pediatric Studies to New Drug Development
A Guide to US and EU Rules

New guidances in the US and EU require drugmakers to include a pediatric component in clinical trials for any new drug that could be used to treat children as well as adults.

Most drug researchers don’t study the potential effects the product could have on children. How can you integrate pediatric studies with your more adult-focused clinical trials?

This report explains the process to follow in both the US and EU as well as requirements outlined in recent FDA draft guidance and European Commission guidelines. It also discusses:

  • How to get a priority review voucher
  • How to get a waiver or deferral
  • The kinds of incentives regulators are offering drugmakers to conduct pediatric research
  • How Canada, Japan and Switzerland are addressing the pediatric research issue
  • Potential future developments  

Stay on top of new pediatric research regulations. Order your copy of Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules today.

 

PDF Edition

 

 

Available Format

PDF Edition — $397

 
Note: This publication will be available in PDF format by Nov. 9, 2016.

Who Will Benefit

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

 

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email customerservice@fdanews.com

© 2016 FDAnews