Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff

Name: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: combination-products,draft,fda,guidances,industry,pma,post-approval,pre-market-authorization,submissions

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Combination Products

Published

January 18, 2013

Last updated

May 13, 2021

Description

Draft guidance for industry and FDA staff on submissions for postapproval modifications to combination products approved under a BLA, NDA, or PMA.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff

Updated on May 13, 2021

pdf (101.2KB)

URL: https://www.fda.gov/media/85267/download
Permalink: https://data.openrid.co/en/datasets/r/34bf7479-1808-45ce-bb3d-58d4fe353471
MIME Type: application/pdf

Created on: January 18, 2013
Modified on: May 13, 2021

Size: 101.2KB

Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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