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2005, 2, Drugs and the pharmaceutical sciences, ISBN 9780824754648, Volume 144, 492
.... It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices... 
Drugs | Law and legislation | Pharmacy | Pharmaceutical Manufacturing | Pharmaceutical Science Regulatory | Analysis & Pharmaceutical Quality | United States
eBook
2008, 2nd ed., ISBN 9780873897402, xxx, 304
"This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality... 
Law and legislation | Medical instruments and apparatus industry | Quality control | United States
Book
2012, 1st ed., ISBN 9780123919113, xxxiii, 638
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial... 
Drugs | Clinical trials | Testing
Book
2011, ISBN 9780873898164, xxxv, 328
The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food... 
Safety regulations | Design and construction | Medical instruments and apparatus industry | Medical instruments and apparatus | United States
Book
Journal Article
2009, 2nd ed., ISBN 047019510X, xiii, 466
"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small... 
Technology, Pharmaceutical | methods | Drug Design | Clinical Trials as Topic | Drug Approval | legislation & jurisprudence | Drug development | Chemistry, Pharmaceutical | Drugs | Research
Book