FDA creates pediatric review agency

Share this article:
FDA commissioner Andrew von Eschenbach has approved creation of an agency Pediatric Review Committee (PeRC) to provide consultation on and general review of pediatric information submitted to the FDA in pediatric plans, assessments, and studies conducted by sponsors and applicants.

A memo by deputy commissioner Janet Woodcock said PeRC will among other items: review all written requests before issuance; may review studies submitted in response to a written request to make a recommendation on exclusivity determinations; will provide consultation to reviewing divisions on all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required; and will provide review of all deferrals and waivers from the requirement to submit assessments.

Woodcock said PeRC will conduct a retrospective review and analysis of a representative sample of assessments submitted and deferrals and waivers.

Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Read the complete April 2014 Digital Edition

Read the complete April 2014 Digital Edition

Click the above link to access the complete Digital Edition of the April 2014 issue of MM&M, with all text, charts and pictures.

Antidote: Are e-cigarettes safe?

Antidote: Are e-cigarettes safe?

The pros and cons of e-cigarettes

Combating concept churn

Combating concept churn

There's no cure. But the good news is that prophylaxis is possible.