What is FDA Form 3794?

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)

What is the purpose of 1572?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

What is the difference between 1571 and 1572?

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

When should 1572 be submitted?

When a new investigator is added to the study (21 CFR 312.53(c)). It must be completed and signed before an investigator can participate in a clinical investigation. in section #9 of the Form FDA 1572.

What is the difference between 3542 and 3542a?

Form 3542a should be used when submitting patent information with original NDA submissions, NDA amendments and NDA supplements prior to approval. Form 3542 should be used after NDA or supplement approval. This form is to be submitted within 30 days after approval of an application.

What is FDA Form 3542?

Use this Form FDA 3542 only if the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug. If the NDA holder is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, you must use Form FDA 3542a.

What is the purpose of FDA Form 1571?

The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.

Who needs to be added to the 1572?

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

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Q: What is the purpose of FDA Form 1571?

The FDA Form 1571 or &#039;1571&#039; is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.

If the patent referenced above has been submitted previously for listing is the expiration date a new expiration date FORM FDA 3542 11/13 Page 1 PSC Publishing Services 301 443-6740 EF For the patent referenced above provide the following information on each patent that claims the drug substance drug product or method of use that is the subject of the approved NDA or supplement. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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