HEALTH CARE AND LIFE SCIENCES
LEGAL GUIDE TO THE BUSINESS OF MARIJUANA
CANNABIS , HEMP AND CBD REGULATION
James T . O ’ Reilly ( University of Cincinnati ) and Edgar Asebey ( Keller Asebey Life Science Law PLLC )
This helpful resource for practitioners , cannabis growers , retailers , and other players elucidates upon the regulatory pressures affecting cannabis , hemp , and cannabidiol businesses . This deskbook is authored by a pair of esteemed public health policy practitioners who have worked on varied projects and matters involving Food and Drug Administration compliance and public health matters .
Cannabis stakeholders and advisers will find a plethora of case studies , practical insights , and in-depth guidance on the political and public policy issues that impact them and their enterprises on the state and federal levels .
Track important cannabis , hemp , and cannabidiol regulatory developments with PLI ’ s Upkeep Service .
1 softbound volume or digital , 578 pages , $ 289 , Item # 308191 , ISBN 978-1-4024-4335-0 , Updated annually or as needed
CONTENTS
1 The Big Picture 2 Elements of Federal Conflict with State
Marijuana Legislation 3 Understanding the Diverse Terms of State
Marijuana Legislation 4 Medical and Prescribing Issues for Marijuana Patients 5 Roles of Criminal Law 6 Non-Smoked Forms of THC Delivery : Pills , Oils , Food , and E-cigarettes 7 The Business of Marijuana 8 Tax Issues 9 Employment Issues 10 Growing and Processing of Marijuana 11 Vehicle Driving Risks and Enforcement 12 Professional Licensure and Ethical Constraints 13 Transportation , Customs , and Delivery Issues 14 Role of Local Regulators and Administrators 15 Products Liability and Cannabis Products 16 Regulation of Hemp , CBD , and Psychedelics
Appendices
A Agricultural Improvement Act of 2018 : Selected Provisions
B Department of Agriculture , Agricultural Marketing Service , Final Rule : Establishment of a Domestic Hemp Production Program
C Selected State Cannabis , Hemp , and CBD Laws and Regulations
Index
MEDICAL DEVICES LAW AND REGULATION ANSWER BOOK
Edited by Suzan Onel ( Kleinfeld , Kaplan & Becker , LLP ) and Karen M . Becker ( Precision for Medicine )
This question-and-answer book offers detailed , comprehensive conversations on the pre-market requirements and post-market regulation affecting medical devices and their manufacturers . Readers will find insightful , easy-to-follow discussions from a group of esteemed health care lawyers and professors — all of whom have counseled clients on FDA compliance and enforcement matters .
Anyone who counsels or works for a device manufacturer or health care regulatory agency will find instructive discussions of the premarket and post-market requirements and considerations around medical devices , including 3D-printed devices , devices used with regenerative therapies , combination products , restricted devices , custom devices , and radiological products .
Keep up with new medical device requirements with PLI ’ s Upkeep Service .
1 softbound volume or digital , 1,350 pages , $ 263 , Item # 305222 , ISBN 978-1-4024-4162-2 , Published annually or as needed
CONTENTS
Table of Abbreviations 1 Overview of the Legal Framework for Medical Device Regulation in the
United States 2 Clinical Studies of Investigational Devices 3 Device Premarket Submissions 4 Other Device Categories : Radiological Devices , Restricted Devices , Custom Devices , 3D Printed Devices , Device Accessories , and Devices Used with Regenerative Therapies 5 Combination Products That Include Medical Devices 6 Regulation of Software , Digital Health , and Medical Information Technologies 7 In Vitro Diagnostic ( IVD ) Devices 8 The Quality System Regulation 9 Device Facility Inspections 10 Postmarket Considerations 11 International Considerations 12 Interacting with FDA 13 Enforcement and Government Investigations Relating to Medical Devices 14 Continuing Medical Education ( CME ) and Industry-Supported
Scientific Activities 15 Intellectual Property Considerations for Medical Device Companies 16 Licensing , Product Development , and Commercialization 17 Fraudulent and Abusive Practices in the Reimbursement for Medical Devices 18 HIPAA ’ s Impact on the Medical Device Manufacturing Community 19 Litigation , Products Liability , and Preemption 20 FDA Criminal Enforcement 21 Overlapping Jurisdiction with Other Agencies and Law Enforcement Entities 22 Emergency Use Authorizations and Other Special Policies and Approaches to the COVID-19 Pandemic
Index
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