FDA Publishes Final Rule on Citizen Petitions That Seek to Delay Generic Approvals

On November 8, 2016, FDA announced a final rule (81 FR 78500) amending citizen petition regulations (21 CFR 10). The new rule is meant to ensure the agency does not delay the approval of a pending ANDA, 505(b)(2) or biosimilar application filed under section 351(k) of the PHS Act, unless that delay is necessary to protect the public health. The final rule takes effect January 9, 2017 and may be read here. Contact us for scientific writing, comments to a docket, citizen petitions, literature searches, etc.