The Office of Generic Drugs started to send out official correspondence saying that an amendment submitted without a verification statement is deficient, because it is not reflecting a new ANDA section of Code of Federal Regulations - 21 CFR 314.96(d). This regulation states as follows:
Patent certification requirements. An amendment to an ANDA is required to contain an appropriate patent certification or statement described in Sec. 314.94(a)(12) or a recertification for a previously submitted paragraph IV certification if approval is sought for any of the following types of amendments:
a) To add a new indication or other condition of use;
b) To add a new strength;
c) To make other than minor changes in product formulation; or
d) To change the physical form or crystalline structure of the active ingredient.
If the amendment to the ANDA does not contain a patent certification or statement, the applicant must verify that the proposed change described in the amendment is not one of the types of amendments described above.
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