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0 MB Co intro l No. 06600038 Expiration Date: 8/3 1/ 20162. Award or Grant. S. Department of CommerceNumber:Performance Progress Report 1. Recipient Namesake of Ida ho Military Division n16105130164.

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How to fill out expiration dating extensionfda

01

Determine the expiration dating period needed for the product based on stability testing results.

02

Submit a request for expiration dating extensionFDA to the appropriate regulatory agency.

03

Provide supporting data and documentation to justify the need for the extension, including stability testing results and any changes to the product formulation or manufacturing process.

04

Await approval from the regulatory agency before implementing the new expiration dating on the product labeling.

Who needs expiration dating extensionfda?

01

Manufacturers of pharmaceutical products who have conducted stability testing and determined that an extension of the expiration dating period is necessary to ensure the safety and efficacy of their products.

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What is expiration dating extensionfda?

Expiration dating extensionfda refers to extending the expiration date of a product approved by the FDA.

Who is required to file expiration dating extensionfda?

Manufacturers or distributors of products regulated by the FDA are required to file expiration dating extensionfda.

How to fill out expiration dating extensionfda?

Expiration dating extensionfda can be filled out online on the FDA website or by submitting a paper form to the FDA.

What is the purpose of expiration dating extensionfda?

The purpose of expiration dating extensionfda is to allow manufacturers to extend the expiration date of their products based on new data or testing.

What information must be reported on expiration dating extensionfda?

The expiration dating extensionfda must include information on the product, the reason for the extension, and supporting data or test results.

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