Forms | FDA - U.S. Food and Drug Administration
Listing of all external Forms both OMB approved and state using ORA forms.
Form FDA 3674 - Certifications to Accompany …
To assist sponsors, industry, researchers, and investigators in complying with the requirement, we created a certification form (Form FDA 3674) to be used to satisfy the certification...
Online Applications for Export Certificates for Food | FDA
Dec 12, 2022 · Industry may request most types of FDA-issued export certificates for food products through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS).
Form 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.
Special Documents - International Trade Administration
U.S. Food & Drug Administration (FDA) can issue special certificates depending on the product to be exported: Certificate of Free Sale - for food, including dietary supplements, and cosmetic products that may be legally marketed in the United States.
NOTE: At this time the Certificate of a Pharmaceutical Product is the only certificate type that can be requested online. For the Simple Notification, please fill out and send the appropriate application form to the following address: U.S. Food and Drug Administration . Center for Drug Evaluation and Research
Downloadables - Food and Drug Administration
Download. Application form is downloaded from www.fda.gov.ph. The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments and other certifications. Promos and advertisements are also now covered in the application form.
Certifying Pharmaceutical Exports An Introduction To FDA's Certificate …
Feb 1, 2021 · FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requesting country.
Importer Certification Statement | Import Permit Program | CDC
Aug 15, 2024 · Certification statement. We recommend that the Importer Certification Statement includes the following: A statement the material is not known or suspected of containing an infectious biological agent or has been rendered non-infectious. A detailed description of the material being imported. One of the following:
Food Export Certificates | FDA
Sep 15, 2022 · The “Certificate of Exportability” is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States...