Title: New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients
Author: Lawrence T. Friedhoff (PSPG Publishing)
Price: FREE
Rating: 4.3 out of 5 stars (9)
Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants…