| There is no other book at all like FDA-INSIDE AND OUT. It is a true original which should eventually find a respected place in every medical, science, and law library, every drug and med-device company office, (and for savvy biotech investors too) hospitals with IRBs conducting clinical research, all government offices that have oversight on health matters---and in the hands of of every patient rights and consumer advocate organization, as well as investigative health, medical and science reporters. I write this as a medical journalist of 42 years experience, and as co-founder of the National Women's Health Network. On a great many occasions, the behavior and the decisions of FDA have struck me as puzzling and unfathomable (although, on the whole, I still retain an abiding respect for the agency, which impacts daily on so many aspects of our health and welfare.) With Dr. Parisian's book I am starting to grasp how the FDA really functions. WHAT THE BOOK OFFERS. Nothing like it has previously existed, no single reference has explored the entire FDA as one structural entity, looking at the overall process of product regulation, and evaluation of clinical trials. The science surrounding FDA's past and present activities includes discussions of such wide-ranging issues as patient treatment," off-label "use of prescription drugs, veterinary products, vaccines, food safety, milk, genetic engineering, cosmetics, testing of military personnel, informed consent, IRB, BSE and Mad Cow Disease. There is quick reference to legal issues regarding FDA''s regulation of medical products, as well as chapters on FDA's history and development and a good index with fast reference for finding cited regulations. If it's essential to your own work to unravel the "mysteries" of FDA , Dr. Parisian's monumental tome is THE place to start. |
FDA Inside and Out Books In Print, Audio Books.