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§207.29. What are the requirements for reviewing and updating registration information? — Inbound Citations

21 C.F.R. § 207.29

Cited by 1 regulation in release Current.

Citations to §207.29(b)

  • (2) For each listed drug, certify that no changes subject to reporting under paragraph (b)(1)(iv) of this section have occurred if no such changes have occurred since the last review and update. If a drug is discontinued and FDA has received the information required under paragraph (b)(1)(ii) of this section, no further certifications are necessary for the discontinued drug. After initial electronic listing, registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the annual registration update under § 207.29(b) applicable to all of the registrant's listed drugs for which no changes have been made since the previous annual registration update.