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Reset Form. Form Approved: OMB No. 0910-0338. Food and Drug ... Does this product have an FDA ... Refer to the instruction sheet (Form FDA 356h Supplement) for more information. Establishment Name.

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PDUFA Related content

FORM FDA 356h
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CO-JDF-1403 US-01410BG Ivf Writing Specialty Pharmacy Request Form

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Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA.

(c) Individuals or establishments under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment to become components of a biological product are exempt from registration and ...

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.

Form FDA 356h serves as both a summary of administrative information, as well as a repository of complete information on the locations of all manufacturing, packaging, and control sites for both drug substance and drug product facilities associated with the application.

The FEI number is needed by the Agency to proceed with the facility evaluation portion of the application assessment. 21 CFR 207.21(a) states that “Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug…”

Almost all types of businesses need an Employer Identification Number (EIN). An EIN (which is also known as a Federal Employer Identification Number or FEIN) is issued by the IRS and is used to identify a business in much the same way as a Social Security Number (SSN) is used to identify an individual.

An FDA Establishment Identifier (FEI) Number is issued to track inspections of regulated medical device or drug establishments. FEI numbers are also used to track establishments user fee payments. Unlike the FDA Registration Number, the FEI has 10 digits.

To apply to market a new drug, biologic, or an antibiotic drug for human use, you need to complete Form 356h. Form 356h includes information such as applicant information, proposed indication, establishment information, and more.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232