Complete Response Letters
CooperSurgical, Inc.: Paragard
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Dec 18, 2023
Federal Food, Drug, and Cosmetic Act for Paragard (intrauterine copper contraceptive).
CRL_NDA018680_20231218:p1:s11We also acknowledge receipt of your amendment dated November 20, 2023, which was not reviewed for this action.
CRL_NDA018680_20231218:p1:s12This "Prior Approval" efficacy supplement to your application provides for a new inserter intended to facilitate the single-hand placement of Paragard.
CRL_NDA018680_20231218:p1:s13Satisfactory inspection is required before this application may be approved.
CRL_NDA018680_20231218:p1:s19Paragard, we recommend you include that version as draft labeling in your resubmission.
CRL_NDA018680_20231218:p1:s33We have the following Carton Labeling and Placement Guide recommendations that are not approvability issues:
CRL_NDA018680_20231218:p1:s36FDA recommends that the human-readable expiration date on the drug package label include a year, month, and non-zero day.
CRL_NDA018680_20231218:p1:s45FDA recommends that a hyphen or forward slash separate the portions of the expiration date.
CRL_NDA018680_20231218:p1:s49Procedure before initiating Paragard insertion because different inserters perform differently."
CRL_NDA018680_20231218:p2:s17We recommend revising the bolded terms to be consistent with the titles of the specific labeling to which it is referring.
CRL_NDA018680_20231218:p2:s23More Complete Response Letters
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