Updated Form FDA 1571

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FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018. This new version includes a revision date of “(07/18)” in the footer of each page.updated form fda 1571

A side by side comparison of this July 2018 version to the previous version reveals no obvious changes, other than the revision date in the footer. The expiration date of the form remains February 28, 2019, and FDA has posted no additional information about this updated form.

The April 2018 version had an FDA-acknowledged issue where the form caused certain older versions of Adobe Acrobat to crash when attempting to open and/or modify the form. We have learned from clients and colleagues who experienced the issue that it is no longer present in the new July 2018 version.

Back in May, we shared updates to FDA Form 356h and FDA Form 3674, as well. Those forms remain unchanged so read “Updates to Common FDA Forms” if you already have copies of these forms and are trying to determine if they are the current versions.

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Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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