The Complete Connected Pharmaceutical and Medical Devices Laws & Regulations CD-ROM (AHLA Members)
American Health Lawyers Association Elizabeth Carder-Thompson, Esq.; Pamela J. Furman, Esq., Editors
Note: AHLA CD-ROM products are not compatible with Macintosh PC.
If you are not an AHLA member and would like to purchase this book, click here.
The Complete "Connected" TM Pharmaceutical and Medical Devices Laws & Regulations. This CD is a comprehensive and up-to-date compilation of the information you need to understand the regulation of the pharmaceutical, medical devices, and biologics industry. Based on the Folio platform, the CD-ROM is fully searchable, easy to navigate, and is linked to the full text of the sources you need - so there's no need to go online! Included on this CD-ROM you will find the materials you need at your fingertips:
• FDA Modernization Act of 1997
• Patentability of Inventions
• Licensing of Biological Products and Clinical laboratories
• Federal Anti-kickback Law
• Provisions Applicable to Specific Products Subject to the Federal Food, Drug & Cosmetic Act
• Regulatory Hearings before the Food and Drug Administration
• Protection of Human Subjects
• Prescription Drug Advertising
• Investigational New Drug Application
• Medicare Modernization Act
• Foreign Corrupt Practices Act
• FDA Guidance
• State Laws
• Settlement and Corporate Integrity Agreements
• Pharma Code of Conduct Plus the CD contains over 200 full text cases, including the recent decision by the United States Supreme Court in Riegel v. Medtronics.
In addition, the CD-ROM also contains in-depth coverage of the primer Fundamentals of Life Sciences. Contents include, Regulation of Drugs; Regulation of Medical Devices; Regulation of Biologics; Clinical Trials; Fraud and Abuse; Federal Agencies; Regulation of Advertising, and Promotion of Drugs, Medical Devices, and Biologics; Antitrust; Privacy; State Regulation; Intellectual Property; Payment and Reimbursement; International Issues.
ABOUT THE EDITORS
ELIZABETH CARDER-THOMPSON, ESQUIRE, is a partner with ReedSmith in their Washington, DC office. She represents associations and individual providers and suppliers of health services, including hospitals, physicians, hospices, pharmaceutical manufacturers, suppliers and manufacturers of medical devices, nursing homes, home health agencies, CORFs, and suppliers of diagnostic, laboratory, and other services, as well as financial services firms that support the health care industry. PAMELA J. FURMAN, ESQUIRE, is a partner in King & Spalding's FDA/Healthcare Practice Group. Ms. Furman joined the firm in 2007, bringing with her more than 12 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues and Investigational Device Exemption (IDE) requirements.
We would also like to thank the authors of Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech. click here.