Get Fda Form 3654 Guidance

Foreign Drug Establishment. Collection of GDUFA fees is initiated by industry by filling out a GDUFA cover sheet, (FDA Form 3794), for each of the following human generic drug user fees: ANDA and PAS (Note that a cover sheet is not required for all ANDA and PAS amendments)

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments.

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.

Guidance documents describe FDA's interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.

The form provides the FDA with the information required of applicants who submit certain human drug, biological product, and device applications, including Investigational New Drug Applications (IND) and new clinical protocols submitted as an amendment to an existing IND.

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”