Changes to Be Reported for Product & Establishment License Application; Guidance | Federal Regulations · Congress.wiki

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FDA

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FDA-1995-D-0288

Changes to Be Reported for Product & Establishment License Application; Guidance

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Description

Docket Status: OPEN

Comment Period OpensJul 28, 2017

Comment Period ClosesMar 23, 2018

Type	Title	Posted	Comments	Status
Supporting Material	Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry	Jul 7, 2021

Total Comments

LICENSE APPLICATIONS

GUIDANCE DOCUMENT

MANUFACTURING PROCEDURES

PRODUCT ESTABLISHMENT

CHANGES REPORTED