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Question-based Review for Generic Drugs Lawrence X. Yu, Ph. D. Director for Science Office of Generic Drugs Food and Drug Administration Workshop on Implementation of ICH2 Q8/Q9/Q10 and Other Quality.

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The date of filing will be the date 60 days after the date FDA received the NDA. The date of filing begins the 180-day period described in section 505(c) of the Federal Food, Drug, and Cosmetic Act. This 180-day period is called the “filing clock.”

ANDA Forms Filing Review of ANDAs MAPP including filing checklist (PDF - 521KB) Form FDA-356h: Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use (PDF - 2.3MB) Instructions for using Form FDA-356h (PDF - 129KB) Instructions for Completing Form FDA 3794 (Generic Drug User Fee Cover Sheet)

9 In contrast to an ANDA, a 505(b)(2) application allows greater flexibility as to the characteristics of the proposed product. A 505(b)(2) application will not necessarily be rated therapeutically equivalent to the listed drug it references.

An Abbreviated New Drug Application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product whereas a New Drug Application (NDA) is the application through which sponsors formally propose the approval of a new pharmaceutical drug.

What is QbR? The QbR, a general framework for the CMC assessment of ANDAs, incorporates the most important scientific and regulatory review questions that focus on critical pharmaceutical attributes essential for ensuring generic drug product quality. The QbR serves two purposes for the CMC assessment of ANDAs.

The RLD is used as a basis for submitting an ANDA; in other words, an abbreviated new drug application (ANDA) for a generic drug is a duplicate of its RLD.

Generic drug companies must perform studies that show that the same amount of drug gets to the bloodstream and that it gets there at about the same time. FDA scientists analyze the results to be sure the generic will produce the same result as the brand-name drug.

The electronic common technical document (eCTD) is the standard format for electronic regulatory submissions for ANDAs.

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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