# FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec 505B of the FD&C Act:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/fdara-implementation-guidance-for-pediatric-studies-of-molecularly-targeted-oncology-drugs-amendments-to-sec-505b-of-the-fdc-act-guidance-for-industry/7a11011d-8bb1-46e2-8382-c4460aea8ec8

> FDA guidance document: FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec 505B of the FD&C Act:  Guidance for Industry. Issue date: May 24, 2021. Get complete insights and analysis.

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## Details

- Title: FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec 505B of the FD&C Act:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2021-05-24
- Comment Close Date: 2020-02-12
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-4751">FDA-2019-D-4751</a>

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