A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Author: Stephen M. Kanovsky
Publisher:
Total Pages: 672
Release: 2020-09
Genre: Drugs
ISBN: 9781935065876

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Complete Guide to Human Resources and the Law, 2020 Edition

Complete Guide to Human Resources and the Law, 2020 Edition
Author: Shilling
Publisher: Wolters Kluwer
Total Pages: 1878
Release: 2019-08-23
Genre: Business & Economics
ISBN: 1543811140

The Complete Guide to Human Resources and the Law will help you navigate complex and potentially costly Human Resources issues. You'll know what to do (and what not to do) to avoid costly mistakes or oversights, confront HR problems - legally and effectively - and understand the rules. The Complete Guide to Human Resources and the Law offers fast, dependable, plain English legal guidance for HR-related situations from ADA accommodation, diversity training, and privacy issues to hiring and termination, employee benefit plans, compensation, and recordkeeping. It brings you the most up-to-date information as well as practical tips and checklists in a well-organized, easy-to-use resource. Previous Edition: Complete Guide to Human Resources and the Law, 2018 Edition ISBN 9781454899945

Complete Guide to Federal and State Garnishment, 2020 Edition (IL)

Complete Guide to Federal and State Garnishment, 2020 Edition (IL)
Author: Bryant
Publisher: Wolters Kluwer
Total Pages: 1292
Release: 2019-12-12
Genre: Business & Economics
ISBN: 1543811132

Complete Guide to Federal and State Garnishment provides much-needed clarity when the federal and state laws appear to conflict. You'll find plain-English explanations of the laws and how they interact, as well as the specific steps you and your staff need to take to respond to the order properly. Numerous detailed examples and mathematical calculations make it easy to apply the law under different scenarios. Written by Amorette Nelson Bryant, who was recently appointed by the Uniform Law Commission as an observer for the Drafting Committee on a Wage Garnishment Act and was a past chair of both the APA GATF Child Support Subcommittee and Garnishment Subcommittee, Complete Guide to Federal and State Garnishment brings the payroll professional up-to-date on the latest federal and state laws and regulations affecting this ever-changing area. It is your one-stop source for answers to critical questions, such as: Does the amount exempt from garnishment change when the minimum wage goes up? How do I determine the wages to which the garnishment applies? If an employee is subject to more than one garnishment, which has priority? Which state's rules do I use when I receive a child support order sent from another state? State or federal law - which applies for creditor garnishment and support? Are there alternatives to remitting withheld child support via EFT/EDI? How do I handle garnishments when employees are paid a draw against salary? Previous Edition: Complete Guide to Federal and State Garnishment, 2019 Edition, ISBN 9781454899921

Medical Device Regulations

Medical Device Regulations
Author: Aakash Deep
Publisher: Academic Press
Total Pages: 187
Release: 2022-01-13
Genre: Technology & Engineering
ISBN: 0323911277

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

The REGTECH Book

The REGTECH Book
Author: Janos Barberis
Publisher: John Wiley & Sons
Total Pages: 970
Release: 2019-08-06
Genre: Business & Economics
ISBN: 1119362172

The Regulatory Technology Handbook The transformational potential of RegTech has been confirmed in recent years with US$1.2 billion invested in start-ups (2017) and an expected additional spending of US$100 billion by 2020. Regulatory technology will not only provide efficiency gains for compliance and reporting functions, it will radically change market structure and supervision. This book, the first of its kind, is providing a comprehensive and invaluable source of information aimed at corporates, regulators, compliance professionals, start-ups and policy makers. The REGTECH Book brings into a single volume the curated industry expertise delivered by subject matter experts. It serves as a single reference point to understand the RegTech eco-system and its impact on the industry. Readers will learn foundational notions such as: • The economic impact of digitization and datafication of regulation • How new technologies (Artificial Intelligence, Blockchain) are applied to compliance • Business use cases of RegTech for cost-reduction and new product origination • The future regulatory landscape affecting financial institutions, technology companies and other industries Edited by world-class academics and written by compliance professionals, regulators, entrepreneurs and business leaders, the RegTech Book represents an invaluable resource that paves the way for 21st century regulatory innovation.

Preventing Regulatory Capture

Preventing Regulatory Capture
Author: Daniel Carpenter
Publisher: Cambridge University Press
Total Pages: 531
Release: 2014
Genre: Business & Economics
ISBN: 1107036089

Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.

Emergency Response Guidebook

Emergency Response Guidebook
Author: U.S. Department of Transportation
Publisher: Simon and Schuster
Total Pages: 352
Release: 2013-06-03
Genre: House & Home
ISBN: 1626363765

Does the identification number 60 indicate a toxic substance or a flammable solid, in the molten state at an elevated temperature? Does the identification number 1035 indicate ethane or butane? What is the difference between natural gas transmission pipelines and natural gas distribution pipelines? If you came upon an overturned truck on the highway that was leaking, would you be able to identify if it was hazardous and know what steps to take? Questions like these and more are answered in the Emergency Response Guidebook. Learn how to identify symbols for and vehicles carrying toxic, flammable, explosive, radioactive, or otherwise harmful substances and how to respond once an incident involving those substances has been identified. Always be prepared in situations that are unfamiliar and dangerous and know how to rectify them. Keeping this guide around at all times will ensure that, if you were to come upon a transportation situation involving hazardous substances or dangerous goods, you will be able to help keep others and yourself out of danger. With color-coded pages for quick and easy reference, this is the official manual used by first responders in the United States and Canada for transportation incidents involving dangerous goods or hazardous materials.

The Complete Guide to OSHA Compliance

The Complete Guide to OSHA Compliance
Author: Joel M. Cohen
Publisher: CRC Press
Total Pages: 408
Release: 2020-11-25
Genre: Science
ISBN: 1000115089

The Complete Guide to OSHA Compliance is an easy-to-understand, one-stop resource designed to help safety professionals, industrial hygienists, and human resources personnel ensure compliance with existing and upcoming OSHA regulations. This essential book explains employer and employee rights and responsibilities, and it provides everything you need to know about employer standards and standards for specific operations. The Complete Guide to OSHA Compliance describes the process of injury/illness recordkeeping and the reporting system required by OSHA. It also explains how to conduct a self-audit to determine whether a company is in full compliance. Furthermore, it informs companies of their rights in an inspection and explains how to handle citations and appeals, should they arise.

The Definitive Guide to Blockchain for Accounting and Business

The Definitive Guide to Blockchain for Accounting and Business
Author: Saurav K. Dutta
Publisher: Emerald Group Publishing
Total Pages: 320
Release: 2020-09-30
Genre: Business & Economics
ISBN: 1789738652

Blockchain is a disruptive technology potentially impacting how economic transactions are recorded, stored, and verified. Despite such ramifications, there is a lack of literature discussing this from the accountant’s perspective. Through real-world cases this book distils an abstract technology to relatable experiences for business professionals.