|
FDA publishes new draft guidance for industry,
“Forms 3542a and 3542: Questions and Answers”
On June 12, the Food and Drug Administration (FDA) published the draft guidance for industry entitled, “Forms 3542a and 3542: Questions and Answers.” This draft guidance will help New Drug Application (NDA) applicants and holders submit patent information to their NDA using Form FDA 3542a or Form FDA 3542, under 21 CFR 314.53(d), by providing answers to commonly asked questions on these forms, divided into three topics:
1) Obtaining and Filling out Forms FDA 3542a and FDA 3542
2) Section 6 of Forms FDA 3542a and FDA 3542 (“Declaration Certification”)
3) Submitting Patent Information to FDA
Determining what form to submit depends on the approval status of the NDA. Form FDA 3542a must be used when an NDA applicant submits information for a patent that claims a proposed drug substance (active ingredient), drug product (formulation and composition), or a proposed method of using the drug that is the subject of an unapproved original NDA, amendment to an NDA, or supplement to an NDA. Form FDA 3542 must be used when an NDA holder submits information for a patent that claims an approved drug substance (active ingredient), drug product (formulation and composition), or an approved method of using the drug to that is the subject of an approved NDA or supplement to an NDA. (see 21 CFR 314.53(c)).
By clarifying the process of submitting patent information using Forms FDA 3542a or FDA 3542, this draft guidance will minimize applicant confusion and errors, save time and the expense of repeated questions to the Agency, and facilitate more timely, complete submissions. As part of FDA’s Drug Competition Action Plan, which seeks to improve the efficiency of generic drug development, review, and approval, the Agency is issuing this guidance to clarify the NDA patent information submission process, which provides greater accuracy, timeliness, and consistency regarding listed patent information, benefitting both NDA and ANDA applicants that rely on this information. As FDA develops any final guidance on this topic, it will consider comments on the applicability of Executive Order 14192, per OMB guidance M-25-20, and in particular, on any related costs or savings.
|
