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You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.
What is a 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.
Form 1572 (PDF - 718KB) (Investigator's statement), and. Form 3674 (PDF - 3MB) (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.
Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).
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People also ask

Emergency Investigational New Drug (EIND) Applications for Antiviral Products.
Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).
Food and Drug Administration. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. DRUG OR BIOLOGIC FOR HUMAN USE.
FDA forms are the way of communication between FDA and the drug manufacturing firms. These forms are issued at different stages of FDA inspection.
Food and Drug Administration. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. DRUG OR BIOLOGIC FOR HUMAN USE.

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