FDA Targets Approval-Delaying Petitions in Final Guidance

September 27, 2019

The FDA featured the misuse of petitions to stall generic drug applications in a final guidance  and spells out how the agency will deal with the petitions.

An amendment to the FD&C Act’s petition regulations, Section 505(q), was signed into law in 2016 to prevent citizen petitions and petitions for stays of action from purposely delaying drug approvals. The section requires the agency to make a final decision within 150 days on petitions containing any requests that could delay a pending generic drug’s approval.

If a petition relates to an ANDA, NDA or BLA that is pending, and requests an action that could hinder an application’s approval, it is subject to the 150-day deadline, the agency says, adding that approvals may not be delayed based on a petition unless there are legitimate public health reasons.

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