FDAnews Drug Daily Bulletin

FDA: Citizen Petitions May Now Be Filed Electronically

Dec. 19, 2013

The FDA is bringing the citizen petition process into the 21st century by allowing for electronic submissions, the agency says in a Federal Register notice published today.

Under the previous process, companies, law firms, advocacy groups and other interested parties submitted citizen petitions by way of written documents.

Starting today, petitioners may submit documents electronically, and only one copy of the submission is needed. The Division of Dockets Management will then assign it a unique docket number, making it easier to track the progress of a submission, the agency says.

The agency will still accept two copies of petitions on paper. Read the Federal Register notice at www.fdanews.com/ext/resources/files/12/12-19-13-CP.pdf — Lena Freund

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