A 667 page reference text about FDA that was several years and a "clinical lifetime" in
the making. The first part of the book focuses on the ENTIRE FDA . There are timely and
representative discussions of "major" issues that have occurred for FDA and the U.S.
public for each of FDA's 6 Centers. The text provides history, development, organization,
science, prior policies and regulatory requirements for FDA .
FDA's 6 Centers
1.Center for Drug Evaluation & Research (CDER)
2. Center for Food Safety & Applied Nutrition (CFSAN)
3.Center for Biologics Evaluation & Research (CBER)
4.Center for Devices and Radiological Health (CDRH)
5.Center for Veterinary Medicine (CVM)
6.National Center for Toxicological Research (NCTR)
The reader is provided with additional resources for obtaining further information, *including helpful internet references. There are discussions of representative examples and cases as well as cited federal regulations with examples of how they have been utilized by FDA.
The second part of the book focuses directly on the design, conductance, monitoring and evaluation of Human Clinical Trials. This section is derived from Dr. Parisian's experience as a clinical trial evaluator and designer, FDA Chief Medical Officer and FDA Clinical Trial Instructor. These chapters include the role of IRBs, clinical investigators, sponsors, and CROs; design of clinical protocols; subject rights and provision of adequate informed consent.
Dr. Parisian concluded the clinical trial section with several chapters regarding major problems (i.e. regulatory nightmares!) that have occurred for clinical trials and marketing applications. The same types of problems which had been discussed while "inside" FDA with reviewers and manufacturers as Chief Medical Officer and Clinical Trials Instructor are now provided "outside" the FDA by Dr. Parisian to her clients and audiences.
The reader obtains a list of agency-related acronyms designed to help the reader decipher the twisted web of "government-speak". There is also a 40 page index.
Dr. Parisian has attempted to create a "complete reference" about the FDA. There has never been such a detailed reference text written about FDA by a former Chief Medical Officer and a "physician" able to provide a rare glimpse into both the medical and regulatory aspects of FDA's products and the conductance of human clinical trials.
FDA Inside and Out
Fast Horse Press
FDA Inside or Out can be purchased from online book sources such as http://www.amazon.com
Inquire with Fast Horse Press
(602) 354-8606 or (602)-354-8567