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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

From Brand: CRC Press




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 | #2980641 in Books |  CRC Press |  2003-12-23 | Original language:English | PDF # 1 |  .77 x6.22 x9.20l, | File type: PDF | 360 pages

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||13 of 14 people found the following review helpful.| Doesn't adequately cover medical device regulation|By T. F. Hurley|Mostly this book covers (perhaps adequately) FDA regulation of the development and approval process of new drugs. These new drugs are (by and large) developed by huge drug companies who doubtless employ teams of lawyers in connection with their FDA submissions and regulatory compliance, and it is quite likely

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescr...

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