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Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition

By Donald O. Beers, Kurt R. Karst
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Overview

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process.

You’ll find comprehensive coverage of:

  • Abbreviated new drug applications
  • 505(b)(2) new drug applications
  • Delaying approval of competing products
  • FDA approval of biologic drugs

No other book can cover the drug approval process as thoroughly, answering important questions like these:

  • What is required to extend the patent of an FDA-approved product?
  • When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application?
  • When does the FDA delay approvals because of patent claims, and when does it ignore patents?
  • How can one challenge an FDA exclusivity decision?
  • When can a manufacturer safely sell a drug without prior FDA approval?
  • In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug?
  • When will the FDA waive or reduce prescription drug user fees?
  • How can a company or an individual avoid debarment?
  • What steps are necessary to comply with the FDA’s Fraud Policy?
  • When and how can a drug company take advantage of FDA accelerated approval procedures?
  • What are the labeling requirements for exporting approved drugs?
  • How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme?

Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of:

  • The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act)
  • The Medicare Prescription Drug, Improvement, and Modernization Act
  • The Food and Drug Administration Modernization Act
  • The FDA Export Reform and Enhancement Act
  • The Biologics Price Competition and Innovation Act
  • And more!

AUTHOR NOTE: Donald O. Beers’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.

Last Updated 04/03/2017
Product Line Wolters Kluwer Legal & Regulatory U.S.
ISBN 9781454836094
SKU 10045841-7777
Table of Contents

Chapter 1. FDA APPROVAL REQUIREMENT

  • §1.01 Marketing New Drugs; General Requirements
  • §1.02 Marketing New Drugs without FDA Approval
  • §1.03 Application of New Drug Definition to Generic Products
  • §1.04 Escaping New Drug Status
  • §1.05 Determination of New Drug Status
  • §1.06 FDA Enforcement Policy

Chapter 2. FULL NEW DRUG APPLICATIONS

  • §2.01 Generally
  • §2.02 New Drug Applications—Content
  • §2.03 New Drug Applications—Procedure
  • §2.04 Supplemental New Drug Applications
  • §2.05 New Drug Applications—Withdrawal of Approval
  • §2.06 New Drug Applications—Suspension of Approval

Chapter 3. ABBREVIATED NEW DRUG APPLICATIONS AND “505(b)(2) APPLICATIONS”

  • §3.01 Generally
  • §3.02 Abbreviated New Drug Applications under 505(j); Qualifying Drugs
  • §3.03 Abbreviated New Drug Applications under 505(j); Contents
  • §3.04 Abbreviated New Drug Applications under 505(j); Procedure
  • §3.05 505(b)(2) Applications

Chapter 4. DELAYING APPROVAL OF COMPETITIVE PRODUCTS

Chapter 5. PUBLIC AVAILABILITY OF DRUG AND BIOLOGIC DATA

  • §5.01 Pending Applications
  • §5.02 Safety and Effectiveness Data
  • §5.03 Information Concerning ANDA Approval Process

Chapter 6. POTENTIAL FOR GOVERNMENT COMPENSATION

Chapter 7. THE ORPHAN DRUG AMENDMENTS

  • §7.01 Orphan Drug Designation
  • §7.02 Orphan Drug Exclusivity
  • §7.03 Other Benefits of Designation

Chapter 8. DEBARMENT AND CIVIL PENALTIES

  • §8.01 Background
  • §8.02 Overview
  • §8.03 Debarment
  • §8.04 Civil Penalties—GDEA
  • §8.05 Civil Penalties—Other
  • §8.06 Suspension of Right to Distribute

Chapter 9. FDA FRAUD POLICY

  • §9.01 Generally
  • §9.02 Applicability and Effect
  • §9.03 Actions Required
  • §9.05 Internal Reviews and Corrective Action Plans
  • §9.06 Validity of the Fraud Policy

Chapter 10. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS AND ACCELERATED APPROVALS

  • §10.01 Background
  • §10.02 Expanded Access to Investigational Drugs for Treatment Use
  • §10.03 Expedited Approval Procedure

Chapter 11. EXPORT AND IMPORT REQUIREMENTS

  • §11.01 Introduction
  • §11.02 Export Requirements
  • §11.03 Imports

Chapter 12. PRESCRIPTION DRUG AND BIOLOGIC USER FEES

  • §12.01 Introduction
  • §12.02 Types of User Fees
  • §12.03 Waivers, Reductions, and Refunds
  • §12.04 Failure to Pay Fees
  • §12.05 Condition for Continuation of Fees
  • §12.06 User Fee Invoicing
  • §12.07 The Quid Pro Quo: FDA Commitments
  • §12.08 Conclusion

Chapter 13. FDA APPROVAL OF BIOLOGIC DRUGS

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