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Showing 1 - 25 of 29 Results


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FDA Deskbook: A Compliance and Enforcement Guide

Treatise  Treatise

Published: May 2016
Last Updated: November 2018

FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. It explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and ...

Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries

Handbook  Course Handbook

Course Handbook from the program Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, held October, 2017.

Developments in Pharmaceutical and Biotech Patent Law 2017

Handbook  Course Handbook

Course Handbook from the program Developments in Pharmaceutical and Biotech Patent Law 2017, held November, 2017.

Pharmaceutical and Biotech Patent Law

Treatise  Treatise

Published: November 2017

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace • invalidate competitors’ patents by proving that they ...

Nuts and Bolts of Medicare & Medicaid 2017: What All Attorneys Need to Know

Handbook  Course Handbook

Course Handbook from the program Nuts and Bolts of Medicare & Medicaid 2017: What All Attorneys Need to Know, held December, 2017.

Health Care Law Institute 2017

Handbook  Course Handbook

Course Handbook from the program Health Care Law Institute 2017, held December, 2017.

Fundamentals of Privacy Law 2017

Handbook  Course Handbook

Course Handbook from the program Fundamentals of Privacy Law 2017, held December, 2017.

Advocacy for Low-Income Children with Disabilities in California 2018

Handbook  Course Handbook

Course Handbook from the program Advocacy for Low-Income Children with Disabilities in California 2018, held April 2018.

Hot Topics in Child Custody, Visitation & Guardianship for New York Practitioners 2018

Handbook  Course Handbook

Course Handbook from the program Hot Topics in Child Custody and Visitation for New York Practitioners 2018, held April 2018.

Psychological Issues in the Workplace 2018

Handbook  Course Handbook

Course Handbook from the program Psychological Issues in the Workplace 2018, held April 2018.

30th Annual Elder Law Institute

Handbook  Course Handbook

Course Handbook from the program 30th Annual Elder Law Institute, held March 2018.

Nineteenth Annual Institute on Privacy and Data Security Law

Handbook  Course Handbook

Course Handbook from the program Nineteenth Annual Institute on Privacy and Data Security Law, held May 2018.

Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition)

Answer Book  Answer Book

Published: May 2018

Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, this resource discusses: The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency A facility's rights and compliance obligations during an inspection by the ...

Legal Guide to the Business of Marijuana

Treatise  Treatise

Published: May 2018

Legal Guide to the Business of Marijuana is a new and unique resource for lawyers who represent clients in what has been called the fastest growing industry in the United States. The majority of states have enacted laws legalizing medical marijuana — with more than a handful of states to date allowing for recreational use — but marijuana remains illegal under the Federal Controlled Substances Act, giving rise to constitutional challenges ...

Health Care Technology 2018: New Risks and How to Plan for Them in Cyber Threats, Digital Medicine, IoT and Technology Agreements

Handbook  Course Handbook

Course Handbook from the program Health Care Technology 2018: Critical Issues in Cybercare, Digital Medicine, and Structuring Effective Agreements, held June 2018.

Health Care Mergers and Acquisitions Answer Book (2018 Edition)

Answer Book  Answer Book

Published: July 2018

M&A activity in the health care industry is at its highest level since the 1980s. Health Care Mergers and Acquisitions Answer Book, co-edited by Andrew L. Bab and Kevin A. Rinker at Debevoise & Plimpton LLP, provides the reader with a roadmap to this booming sector. Organized into four parts, it includes practical advice on how to address the various industry-specific issues arising in health care acquisitions: Part I: Structuring ...

Medical Devices Law and Regulation Answer Book (2019 Edition)

Answer Book  Answer Book

Published: August 2018

Medical Devices Law and Regulation Answer Book 2019 walks you through the current regulatory requirements governing medical devices and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. The organization of this text broadly follows the typical life cycle of a device and covers a broad range of topics, including many that are not commonly ...

Trade Secrets 2018: What Every Lawyer Should Know

Handbook  Course Handbook

Course Handbook from the program Trade Secrets 2018: What Every Lawyer Should Know, held November 2018.

Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries

Handbook  Course Handbook

Course Handbook from the program Life Science 2018: Navigating Legal Challenges in the Drug and Device Industries, held November 2018.

Nuts and Bolts of Medicare & Medicaid 2018: What All Attorneys Need to Know

Handbook  Course Handbook

Course Handbook from the program Nuts and Bolts of Medicare and & Medicaid 2018: What All Attorneys Need to Know, held December 2018.

Hot Topics in Health Care Law 2018

Handbook  Course Handbook

Course Handbook from the program Hot Topics in Health Care Law 2018, held December 2018.

31st Annual Elder Law Institute

Handbook  Course Handbook


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