Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

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New Drug Approvals

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity
The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately.

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http://www.gmp-compliance.org/enews_4352_Stability%20Data%20for%20ANDAs%20in%20the%20USA%3A%20a%20new%20Q%26A%20Document%20of%20the%20FDA%20provides%20further%20Clarity_8445,8489_n.html

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

The FDA Guidance for Industry with the title “ANDAs: Stability Testing of Drug Substances and Drug Products” was published in the Federal Register on 20 June 2013 (also see our News dated 1 August 2013) and is addressed to applicants for ANDAs in the USA. This guidance describes the stability data the FDA expects in the documents submitted for an ANDA and is rather short having…

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