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Form Approved: OMB No. 0910-0284 Exp. Date: 7/31/2023. See PRA statement on pg. 3. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL.

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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.

Look up the drug in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biologic products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.

Specifically, this annual summary must include the name of the investigational drug, the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. FDA is required to specify the deadline for such reporting submissions.

Form FDA 2252 is required to accompany all annual report submissions regarding new information that might affect the safety, effectiveness, or labeling of a drug or biological product for human use.

Form FDA 2253 is the standard form Life Sciences companies need to fill out to start the regulatory review process for their promotional content. Along with all the promotional content associated with a submission, the form gathers the information the FDA needs to review advertisements and promotions all in one place.

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)

Form FDA-2253 - Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (check box #13 “Part II/Final)

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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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