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Fundamentals of US Pharmaceutical and Biologics Regulations (2019, e-book)

E-books     Member: $150.00

Fundamentals of US Pharmaceutical and Biologics Regulations (2019, e-book) HiddenProductTag

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This publication is derived from the 11th edition of Fundamentals of US Regulatory Affairs and focuses on US drug and biologics’ legislation and regulations. It also reviews the history of US food, drug and cosmetic laws and the development of the regulatory environment. Chapters included in this discuss:

  • regulatory pathways
  • Good Clinical Practices (GCPs)
  • prescription drug submissions
  • postmarketing commitments and compliance
  • generic drug submissions
  • OTC drugs
  • prescription drug advertising, promotion and labeling
  • pharmacovigilance and risk management
  • patents and exclusivity 

Specific to biologics are chapters on

  • submissions
  • compliance
  • biosimilars
  • labeling, advertising and promotion
  • blood and blood products

Who Should Use This Publication?

Fundamentals of US Regulatory Affairs is designed for regulatory professionals working on products for the US market at all levels with a focus on pharmaceuticals and biologics. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.

Studying for the RAC? Take a look at our RAC prep resources.

Check out RAPS Fundamentals Series.

ISBN: 978-1-947493-36-0

Published by RAPS © 2019. E-Book. 330 pages.