FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Amendments Made to Citizen’s Petitions to Fight ANDA Delays

Nov. 14, 2016

The FDA has made several amendments to the requirements for filing citizen petitions and petitions for stay of action when used to delay ANDA applications.

In a final rule to be published, all submitters of a petition or (stay of action) should include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known.

Additionally, the document clarifies that the agency will consider the verification deficient unless every word in the petitioner’s or commenter’s verification matches every word of the verification evidence provided.

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