Автор: Ira R. Berry and Robert P. Martin
Название: The Pharmaceutical Regulatory Process, 2nd Edition
Издательство: CRC Press
Год: 2008
ISBN: 978-1420070422
Серия: Drugs and the Pharmaceutical Sciences (Book 185)
Язык: English
Формат: pdf
Размер: 11,1 mb
Страниц: 650
This book focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
pharmacovigilance programs designed to prevent widespread safety issues
legal issues surrounding the sourcing of foreign APIs
the issues of counterfeit drugs
updates on quality standards