Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

News Healthcare & Pharma Reports

Date: 25th Nov, 2024 Source: Food and Drug Administration (FDA) Country: USA Original Source

Brief

The FDA updated its guidance on reviews of pediatric studies conducted under BPCA and pediatric assessments conducted under PREA from 2012 to present. The update aims to provide clarity on the requirements for submitting pediatric information, including the need for a clear and concise format for pediatric reports and the requirement for transparency in the review process.

This content is restricted.

Highlights content goes here...

This content is restricted.

Food and Drug Administration (FDA)

RADA.AI

Hello! I'm RADA.AI - Regulatory Analysis and Decision Assistance. Your Intelligent guide for compliance and decision-making. How can i assist you today?

Suggested

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

Brief

Food and Drug Administration (FDA)

Form successfully submitted. One of our GRI rep will contact you shortly

Thanking You!

Enter your Email

Verify Email

Tell us more about yourself

Select your work area

Select your country

All set.

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

Brief

Food and Drug Administration (FDA)

Form successfully submitted. One of our GRI rep will contact you shortly

Thanking You!

Enter your Email

Verify OTP

Enter your Email

Verify Email

Tell us more about yourself

Select your work area

Select your country

All set.