HEALTH CARE AND LIFE SCIENCES
PHARMACEUTICAL COMPLIANCE AND ENFORCEMENT ANSWER BOOK
Edited by Howard L . Dorfman ( H . L . Dorfman Pharmaceutical Consulting )
FDA DESKBOOK A COMPLIANCE AND ENFORCEMENT GUIDE
Edited by James P . Ellison , John A . Gilbert , Jr ., and Anne K . Walsh ( Hyman , Phelps & McNamara , P . C .)
This Deskbook walks health care practitioners , company leaders , and professionals through the regulatory issues the FDC Act imposes on applicable companies . Readers will receive court-tested insights from practitioners with substantial experience around FDA , DEA , FTC , and other agency disputes .
Readers will find comprehensive coverage of FDC Act compliance and legal considerations . In addition to covering FDA administrative actions , the authors address rules regarding medications , drugs , controlled substances , medical devices , in vitro diagnostic devices , food , dietary supplements , tobacco , animal products , and cosmetics .
Track FDA developments with PLI ’ s Upkeep Service .
1 looseleaf volume , 1,020 pages , $ 490 , Item # 173127 , ISBN 978-1-4024-2647-6 , Updated annually or as needed
CONTENTS
1 FDA Administrative Actions 2 FDA Civil Enforcement Actions 3 FDA Criminal Enforcement Actions 4 Other Authorities Governing FDA-Regulated Entities 5 Over-the-Counter Drugs 6 Drugs : Current Good Manufacturing Practice 7 Drug Compounding 8 Clinical Trials 9 Quality System Regulation 10 Devices : Recalls 11 Devices : Medical Device Reports 12 Devices : In Vitro Diagnostic Devices 13 Human Food and Dietary Supplements 14 Tobacco Products 15 Animal Products 16 Cosmetics 17 Controlled Substances 18 Promotion and Marketing of Prescription Drugs , Biologics , and Devices 19 Health Care Fraud and Abuse Laws 20 Internal Investigations 21 FDA Inspections 22 Issues Arising from Criminal Cases
Table of Authorities Index
Presented in an easy-to-follow question-and-answer format , this title explores the regulatory issues that companies and stakeholders in the pharmaceutical industry face — along with their in-house and outside counsel . Readers will find helpful , grounded guidance from an author with extensive experience counseling pharmaceutical and biotechnology companies on a vast array of compliance , regulatory , and risk management issues .
In addition to a sample FDA close-out letter that readers can reference , treatise owners will discover comprehensive conversational insights that , taken together , offer a roadmap to effective FDA pharmaceutical regulatory compliance .
Follow new FDA initiatives with PLI ’ s Upkeep Service .
1 softbound volume or digital , 946 pages , $ 273 , Item # 318460 , ISBN 978-1-4024-4340-4 , Published annually or as needed
CONTENTS
1 The Role of the FDA in Drug Development : Current Perspectives and Future Initiatives 2 FDA Enforcement — Facility Inspections 3 483s and Warning Letters 4 FDA Regulations and Enforcement Actions Relative to Oversight of
Advertising and Promotion 5 Federal and State Regulation and Enforcement of Pharmaceutical
Manufacturers ’ Advertising and Promotional Activity
6 Regulatory and Compliance Implications of Disseminating Medical Information and the Distinction with Off-Label Promotion : Evolving Theories of Liability
7 Government Oversight of Off-Label Promotion and Dissemination of Scientific Information
8 Food and Drug Administration Amendments Act of 2007 and the Growth of FDA Enforcement Authority
9 Risk Evaluation and Mitigation Strategies ( REMS ) and Related Post-Market Safety Oversight
10 Impact of FDA Regulatory and Compliance Oversight on Product
Liability Exposure of Pharmaceutical Manufacturers 11 Specific FDA Enforcement Tools 12 Criminal Prosecution As a U . S . Food and Drug Administration
Enforcement Tool 13 Pharmaceutical Price Reporting : The “ ABCs ” and “ 123s ” of Compliance 14 The False Claims Act and Enforcement Against Pharmaceutical
Manufacturers 15 The Foreign Corrupt Practices Act and Its Impact on the
Pharmaceutical Industry 16 Collateral Consequences of Violating the Federal Food , Drug , and
Cosmetic Act 17 Prescription Drug Sampling Regulation and Enforcement 18 The Impact of the COVID-19 Pandemic on the Development and
Commercialization of Drugs 19 Over-The-Counter Product Litigation 20 Expediting the Drug Approval Process : Formulating Regulatory Responses to Critical Societal Health Issues While Preserving Scientific Standards
Index
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