Pharmaceutical Compliance and Enforcement Answer Book
Author: Howard L. Dorfman
Publisher:
Published: 2021
Total Pages:
ISBN-13: 9781402438486
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Pharmaceutical Compliance and Enforcement Answer Book
Author: Howard L. Dorfman
Publisher:
Published: 2018-07-03
Total Pages: 0
ISBN-13: 9781402431395
DOWNLOAD EBOOK →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 agencyA facility's rights and compliance obligations during an inspection by the agencyHow to best evaluate a company's potential of being in violation and what to do to mitigate those risksWhat advertising and promotion of prescription drugs is permittedHow product liability issues overlap with FDA enforcement initiativesWhen criminal prosecution is used as part of the regulatory enforcement effortFilled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
Pharmaceutical Compliance and Enforcement Answer Book 2015
Author: Howard L. Dorfman
Publisher:
Published: 2015-05-07
Total Pages: 0
ISBN-13: 9781402423727
DOWNLOAD EBOOK →In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2015 describes: -The FDA's authority and potential actions to regulate prescription drugs and biologics -A facility's rights and compliance obligations -What advertising and promotion of prescription drugs is permitted -How product liability issues overlap with FDA enforcement -When criminal prosecution is used
Pharmaceutical Compliance and Enforcement Answer Book
Author: Howard L. Dorfman
Publisher:
Published: 2019
Total Pages: 526
ISBN-13: 9781402436352
DOWNLOAD EBOOK →Pharmaceutical Compliance and Enforcement Answer Book (2014 Edition)
Medical Devices Law and Regulation Answer Book
Author: Susan Onel
Publisher:
Published: 2016-11
Total Pages: 1112
ISBN-13: 9781402427749
DOWNLOAD EBOOK →This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Corporate Compliance Answer Book
Author: Christopher A. Myers
Publisher:
Published: 2018-11
Total Pages: 2384
ISBN-13: 9781402431197
DOWNLOAD EBOOK →Representing the combined work of more than forty leading compliance attorneys, Corporate Compliance Answer Book helps you develop, implement, and enforce compliance programs that detect and prevent wrongdoing. You'll learn how to: Use risk assessment to pinpoint and reduce your company's areas of legal exposureApply gap analysis to detect and eliminate flaws in your compliance programConduct internal investigations that prevent legal problems from becoming major crisesDevelop records management programs that prepare you for the e-discovery involved in investigations and litigationSatisfy labor and employment mandates, environmental rules, lobbying and campaign finance laws, export control regulations, and FCPA anti-bribery standardsMake voluntary disclosures and cooperate with government agencies in ways that mitigate the legal, financial and reputational damages caused by violationsFeaturing dozens of real-world case studies, charts, tables, compliance checklists, and best practice tips, Corporate Compliance Answer Book pays for itself over and over again by helping you avoid major legal and financial burdens.
Health Care Mergers and Acquisitions Answer Book
Author: Andrew L. Bab
Publisher:
Published: 2018-09-07
Total Pages: 0
ISBN-13: 9781402431289
DOWNLOAD EBOOK →M&A activity in the health care industry is at its highest level since the 1980s. Organized into four parts, this guide includes practical advice on how to address the various industry-specific issues arising in health care acquisitions.
The Chapter 800 Answer Book
Author: Patricia C. Kienle
Publisher:
Published: 2021-09-30
Total Pages: 0
ISBN-13: 9781585286294
DOWNLOAD EBOOK →"Provides explanation of elements of USP Hazardous Drugs' Handling in Healthcare Settings and best practices to comply with the requirements and recommendations of the USP General Chapter"--Pref.
Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
Published: 1998
Total Pages: 32
ISBN-13:
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