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Howard L. Dorfman has written 3 work(s)
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cover image for 9781402426131
Product Description: PLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2016 describes: 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 agency How to best evaluate a company's potential of being in violation and what to do to mitigate those risks What advertising and promotion of prescription drugs is permitted How product liability issues overlap with FDA enforcement initiatives When criminal prosecution is used as part of the regulatory enforcement effort Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book 2016 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations...read more
By Howard L. Dorfman (editor)

Paperback:

9781402426131 | Practising Law Inst, June 7, 2016, cover price $295.00 | About this edition: PLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

cover image for 9781402423727
Product Description: Pharmaceutical Compliance and Enforcement Answer Book 2015 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2015 describes:The FDAs authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agencyA facilitys rights and compliance obligations during an inspection by the agencyHow to best evaluate a companys 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 2015 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations...read more
By Howard L. Dorfman (editor)

Hardcover:

9780443088650, titled "Atlas of Small Animal Surgery" | Churchill Livingstone, July 1, 1992, cover price $150.00 | also contains Atlas of Small Animal Surgery

Paperback:

9781402423727, titled "Pharmaceutical Compliance and Enforcement Answer Book 2015" | 1 edition (Practising Law Inst, May 7, 2015), cover price $295.00 | About this edition: Pharmaceutical Compliance and Enforcement Answer Book 2015 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

By Howard L. Dorfman (editor)

Paperback:

9781402421167, titled "Pharmaceutical Compliance and Enforcement Answer Book 2014" | 1 edition (Practising Law Inst, June 7, 2014), cover price $255.00

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