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2. www.fda.govU.S. Food and Drug Administration

   www.fda.gov

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   2024年7月22日 · The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the...

3. www.fda.gov › consumers › consumer-updates5 Tips for Traveling to the U.S. With Medications | FDA

   www.fda.gov › consumers › consumer-updates

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   5 Tips for Traveling to the U.S. With Medications. Subscribe to Email Updates. Español. You’re returning from a trip overseas and want to bring back over-the-counter drugs from Europe that aren’t...

4. www.fda.gov › cosmetics › voluntary-cosmetic-registration-programVoluntary Cosmetic Registration Program | FDA

   www.fda.gov › cosmetics › voluntary-cosmetic-registration-program

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   2023年8月7日 · FDA's Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the ...

5. www.fda.gov › medical-devices › device-registration-andSearch Registration and Listing | FDA

   www.fda.gov › medical-devices › device-registration-and

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   Search the Registration & Listing database. Establishment Registration and Medical Device Listing Files for Download. Releasable establishment registration and listing information under the ...

6. www.fda.gov › vaccines-blood-biologics › exporting-cberHow to Enter a Certificate to Foreign Government (CFG) ...

   www.fda.gov › vaccines-blood-biologics › exporting-cber

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   • Enter A Certificate to Foreign Government (CFG) Application
   • Navigation
   • Section 1 Requestor Information
   • Section 2 Manufacturer Information
   • Section 3 Distributor Information
   • Section 4 Product Information
   • Section 5 Was The Product Ever Recalled?
   • Section 6 List Country(Ies) For Which The Certificates Are Requested
   • Section 7 Indicate What Product Information Should Appear on The Certificate
   • Section 8 Should The Country Destination Be Listed on The Certificate?

   After you have logged into the FDA Industry Systems, select "Biologics Export Certification Application & Tracking System" (BECATS) from the list of systems available on the FURLS Home Page as shown in Figure 1. Figure 1: FDA Industry Systems Page Once you have selected "Biologics Export Certification Application & Tracking System", you will naviga...

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   At the top of every page during the Enter New Application process, a status bar will track your progress through each step of the online application process as shown in Figure 6 below. Figure 6: Navigation Bar A "Get Help" icon, located at the top right of each step, will provide page specific help. For an overview of all help files available, plea...

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   The requestor is the owner of the account from which the application is filed, and the person requesting the export certificate. The requestor is responsible for completing and signing the application form. Most of the fields in section one are automatically populated based on the information from your Online Administration Account (OAA) and cannot...

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   The manufacturing company is the company that is manufacturing one or more products. This company can be the same as the requestor. If they are the same, check the box "Same as Requestor Information" option. Otherwise, fill out all fields that have be marked with an asterisk (*) as shown in Figure 11. NOTE: You must add at least one manufacturer to...

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   In section 3, you have the option to enter one or more Distributors to your request. This distributor can be the same as the requestor. If they are the same, check the box "Same as Requestor" option. Otherwise, fill out all fields that have be marked with an asterisk (*) as shown in See Figure 14 below. Figure 14: Add Distributor Figure 15: Distrib...

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   In this section, you will be able to add one or more products to your application Please enter the following mandatory fields as shown in Figure 17: 1. Trade Name (English Name Only) 2. Proper Name (English Name Only) 3. Marketing Status Prefix - select the prefix from the dropdown list 3.1. BLA/PLA 3.2. PMA 3.3. 510k 3.4. ANDA 3.5. NDA 4. Marketin...

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   In this section, the system displays all products entered in Section 4 as shown below in Figure 19. Figure 19: Add Recalled Product If any product listed has been recalled in the past ten years, you will need to select the checkbox next to the product and then click on the "Add/Modify Recall Info" button. You will then need to add either the FDA Is...

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   This section is required. *NAME OF COUNTRY or COUNTRIES - Select one or more countries to indicate the product destination. If you have no specific country of destination, you must select "NO COUNTRY DISPLAYED" as shown in Figure 21. NOTE: Another method to select a country (other than scrolling down the list) is to first click on a country from th...

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   Facility or facilities to be displayed on the certificate The system will display a list of all manufacturers and distributors entered in section 2 and 3 as shown in Figure 22. You must select at least one facility to be displayed on the certificate. A maximum of three facilities can be selected to be displayed on the certificate. Once you select t...

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   This section is required. If you selected a country other than "NO COUNTRY DISPLAYED" in section 6, you can select "Yes" to print the destination country on the certificate. The system will display the selected country or countries (from section 6) where you will be able to enter the requested number of certificates for each country as shown in Fig...

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7. www.fda.gov › about-fdaAbout FDA | FDA - U.S. Food and Drug Administration

   www.fda.gov › about-fda

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   White Oak Campus Facilities Headquarters Buildings (excluding White Oak) General information about FDA – its mission, history, organization, partnerships, etc.

8. www.fda.gov › about-fda › what-we-doWhat does FDA regulate? | FDA - U.S. Food and Drug Administration

   www.fda.gov › about-fda › what-we-do

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   2024年3月29日 · FDA Office of Regulatory Affairs. FDA regulates medical products, most food (except some meats, poultry, and egg products that are regulated by the USDA), tobacco, products that give off radiation...