(Ebook) The Pharmaceutical Regulatory Process 2nd Edition by R Berry Ira, Robert P Martin ISBN 1420070428 9781420070422

(Ebook) The Pharmaceutical Regulatory Process 2nd Edition by R Berry Ira, Robert P Martin ISBN 1420070428 9781420070422

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ISBN 10: 1420070428
ISBN 13: 9781420070422
Author: R Berry Ira, Robert P Martin

(Ebook) The Pharmaceutical Regulatory Process 2nd Table of contents:

1 Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act
Introduction: 19Th-Century Background to Drug Regulation In The United States
Early Regulation of Biological Therapies
Federal and Private Regulation of Drugs In The Early 20Th Century
The Drug Marketplace At The Turn of The Century
The Federal Food and Drugs Act of 1906
Applying The New Law to Drugs
Toward The 1938 Food, Drug, and Cosmetic Act
Drug Regulation and The Postwar Chemotherapeutic Revolution
Coming to Grips With Efficacy Before 1962
Kefauver, Kevadon, and A New Approach to Drug Regulation
Conclusion
References and Notes

2 Modernizing the Food and Drug
Introduction and Overview
Pediatric Studies
Mandatory Pediatric Assessment
Pediatric Studies Exclusivity
Clinical Trial Registry and Results Database
Preapproval Issues
Combination Products
Critical Path Initiative
Accelerated Approval of Priority Countermeasures
Priority Review to Encourage Treatments for Tropical Diseases
Antibiotic Drugs
Advisory Committee Referral
Single-Enantiomer Exclusivity
Postapproval Issues
Reports of Postmarketing Approval Studies
Prescription Drug Safety Information for Patients and Providers
Public Availability of Drug Approval Package
Prescription Drug Distribution
Other Issues
Importation of Prescription Drugs
Adverse Event Reporting for Nonprescription Drugs
Toll-Free Number for Adverse Event Reporting
Citizen Petitions Affecting Generic Drug Approvals
Prohibition Against Food with Added Drugs or Biological Products
Pharmacy Compounding
References

3 The New Drug–Approval Process—Before and After 1962
Introduction
The Federal Food and Drugs Act of 1906
The 1912 Shirley Amendment
1938 Federal Food, Drug, and Cosmetic Act
Statutory Drug-Approval Provisions
The 1938 “Grandfather” Provisions and ‘‘Old Drug’’ Status
Regulation of Antibiotics and Insulin
The Drug Effectiveness Amendments of 1962
Approval Provisions
The 1962 Grandfather Clause
The DESI Review and the Imposition of Effectiveness on Pre-1962 Drugs
Important Legal Developments Regarding the 1962 Amendments
The Post-1962 Era
The Orphan Drug Act of 1983
The Era of Shifting Priorities
The User Fee Act of 1992
References and Notes

4 Generic Drug-Approval Process: Hatch–Waxman Update
Overview of Generic Drug-Approval Process Under Hatch-Waxman
Listing Patents In The Orange Book
Requirements
Challenges to Listing
Delisting and Relisting
Abbreviated New Drug Applications
The “Listed” Drug
Establishing Equivalence to the Listed Drug
Additional Requirements
Suitability Petitions for Drugs That Differ From Listed Drug
Removal of Orange Book Listing of a Drug
Approval of Generic Drugs Under Section 505(B)(2)
Reliance Upon Literature
Variants of Listed Drugs
Fda Action on Andas and 505(B)(2) Applications
Patent Certifications
Types of Certifications
Content of Certifications
Notice to Patent Owner and Holder of Nda Accompanying Paragraph Iv Certification
Section VIII Statement of Listed Use Patents Which Do Not Cover Indications for Which Approval Is Sought
Amending ANDAs or 505(b)(2) Applications to Make Paragraph IV Certifications
The Safe Harbor Exemption From Patent Infringement
Submission of An Anda Or 505(B)(2) Application As An Act of Patent Infringement
Scope and Jurisdiction of Infringement Actions Commenced Under 35 USC §271(e)(2)
Right of ANDA or 505(b)(2) Applicants to Seek Declaratory Judgments
Right of Patent Owners to Seek Declaratory Judgments
Delays In The Approval of Andas and 505(B)(2) Applications
Patent-Related Delays
Delays Attributable to Patent Term Extensions
Section 156 Term Adjustments
URAA Extensions
The 30-Month Stay
180-Day Marketing Exclusivity forANDAs
SeparateExclusivityPeriodsforDifferentDosageForms andDifferentListedPatents
Commercial Marketing of the Generic Drug by a First Applicant Triggers the 180-Day Exclusivity
The Effect of a “Court Decision” on Approval of an ANDA and Triggering of the 180-Day Exclusivity
The First ANDA Applicant(s) Making a Paragraph IV Certification is Awarded Exclusivity
Transfer or Waiver of Exclusivity
Forfeiture of Exclusivity
Delays in ANDA or 505(b)(2) Approvals Based on Marketing/Data Exclusivities
15-Year Exclusivity for New Chemical Entities
3-Year Exclusivities for NDAs or Supplemental NDAs Based on New Clinical Investigations
PediatricExclusivity
The Revocation ofApproval to MarketApotex’s Generic Omeprazole
Mylan’s 180-Day Exclusivity to Market Generic Amlodipine
FDA Procedures for Resolving Marketing Exclusivity Issues
Withdrawal of Approval of An Anda
Citizen Petitions
References and Notes

5 FDA Regulation of Biological Products
Introduction
History of Biologics Regulation
The Biologics Control Act of 1902
The Public Health Service Act
The Cutter Incident, Continuing Controversy, and Eventual Transfer of Biologics Regulation to FDA
The Biotechnology Revolution and Regulation of Recombinant Products
Evolution of the Agency Review Process for Various Biologics
Harmonization of the Drug and Biologics Review Process: PDUFA, FDAMA, and the Transfer of Therapeutic Proteins to CDER
What Is A Biologic? Current Statutory and Regulatory Definitions
Product Jurisdiction
Biologic Vs. Drug
Biologic Vs. Device
Combination Products Featuring a Biologic
Regulatory Process and Approvals General
Approval and Postapproval Requirements
Vaccines
Blood
Tissue
Cellular and Gene Therapy
Pharmacogenomic Pairings
Follow-On Biologics
Scope of Products Eligible for the Pathway
Approval Standard and Data Requirements
Interchangeability
Naming of FOBs
Data Exclusivity
Patent Provisions
Conclusion
References

6 FDA’s Antibiotic Regulatory Scheme: Then and Now
Introduction
Antibiotics Regulation: A Brief History
The Certification Process
Exemptions from Certification Requirements
Fdama
FDA’s Proposed Rule
Fda’S Guidance
A Return to The Definition of Antibiotic
Conclusion
References

7 Generic Drugs in a Changing Intellectual Property Landscape
Introduction
Life-Cycle Strategies for Branded Products
Patent Strategies
Introduction
Initial Filing Strategy
Patent Drafting Strategy
Patent Prosecution Strategy—Continuing Prosecution
Patent Prosecution Strategy—Maximizing and Enhancing Term
Citizen Petitions
Current Issues of Importance to The Generic Industry
Patent Validity Issues
Validity in General
Patent Claims Are Not Valid If They Are Anticipated Or Obvious
Anticipation
Obviousness
Patent Claims Must Also Satisfy the Requirements of 35 USC § 112
The Written Description Requirement
Enablement
Best Mode
Distinct Claiming
“Double Patenting” Is Prohibited
The True Inventors Must Be Named
Practical Application
Patent Infringement Issues
General Infringement Concepts
Construction of Claims
Closed, Partially Closed, and Open Terminology
Infringement
All Elements Rule
Doctrine of Equivalents
Prosecution History Estoppel
Prior Art Can Limit the Scope of Application of the Doctrine of Equivalents
Practical Application
Direct and Indirect Infringement
Willful Infringement
Preliminary Injunctions
Requirements
Reasonable Likelihood of Success on the Merits
Irreparable Harm
Balance of Hardships
Public Interest
Inequitable Conduct
Ftc Scrutiny of Agreements With Generics
History of FTC Scrutiny of Settlement Agreements
The FTC’s Attention Has Shifted to Reverse Payments
Agreements That Forfeit the 180-day Generic Market Exclusivity or Settlements That Covered Noninfringing Products Are Per Se Violations of Antitrust Laws
FTC Enforcement Action Regarding the Abbott-Geneva Hytrin® and Hoescht–Andrx Cardizem CD® Agreements
FTCEnforcementActionRegardingtheBristol-MyersSquibbAgreements
Court Rulings on Agreements That Forfeit the 180-day Generic Market Exclusivity or Settlements that Covered Noninfringing Products Also Finding Them Are Per Se Violations of Antitrust Laws
The Abbott–Geneva Settlement Agreement on Hytrin® Private Antitrust Action
The Hoechst Marion Roussel and Andrx Settlement Agreement on Cardizem CD® Private Action
The BuSpar® and Taxol® Private Antitrust Action
Courts Rulings Regarding the FTC’s Enforcement Actions Against Settlement Agreements Involving Reverse Payments
The Schering-Plough Settlement Agreements With Upsher and ESI
The Tamoxifen Settlement Agreement
Outlook
Conclusions
References and Notes

8 The Influence of the Prescription Drug User Fee Act on the Approval Process
Summary of The Prescription Drug User Fee Act of 1992 (Pdufa I) (Oct. 1,1993, to Sept. 30,1997)
Nature of the Deal
Type of User Fees
Application Fees
Who Pays?
Fee Schedule
Payment Terms
Drug Establishment Fees
Who Pays?
Prescription Drug Establishment
Fee Schedule
Payment Terms
Drug Product Fees
Who Pays?
Fee Schedule
Payment Terms
Performance Goals
Small Business Exception
Fee Waiver or Reduction
Increases and Adjustments
Appropriated Fee Amounts
Effect of Failure to Pay Fees
Annual Reports
Five-Year Sunset
Animal Drug Study
Summary of Fda Modernization Act of 1997 (Pdufa Ii) (Oct. 1, 1997, to Sept. 30, 2002)
Modifications of Prior Law
New Fee Amounts
Performance Goals
Summary of Prescription Drug User Fee Amendments of 2002 (Pdufa Iii) (Oct. 1, 2002, To—Sept. 30, 2007)
Modifications of Prior Law
New Fee Amounts
Performance Goals
Impact of User Fees on Rx Drug Approvals
Summary of Prescription Drug User Fee Amendments of

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