New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients (Paperback)

During his 30-year career in pharmaceutical research and development, author Lawrence T. Friedhoff, MD, PhD, FACP has amassed an extraordinary record of industry accomplishments, most notably as the head of the teams that chose, developed, and brought two chemical compounds through regulatory approvals around the world. These new drugs are market “blockbusters,” each used by millions of patients and each generating well over $1 billion annual revenue worldwide. Dr. Friedhoff's first-hand knowledge of pharmaceutical R&D is extensive and comprehensive: he has held management positions at multi-national corporations developing novel drug compounds, small publicly-traded companies manufacturing generic drugs, start-up ventures, and academic-based research teams writing business plans to obtain venture capital. As an R&D head, he held primary responsibility for choosing drug candidates and preparing comprehensive plans for, as well as managing all phases of, their development, always with an eye towards fulfilling FDA (and often, European and Asian) drug requirements. He has also managed post-FDA-approval activities including collecting and analyzing adverse-event information from consumers, fielding inquiries from patients and healthcare providers, and marketing-related scientific studies. Although the press contains numerous reports of disastrous failed clinical trials, during Dr. Friedhoff's career none of the completed pivotal clinical trials for which he was fully responsible ever failed and all of his new drug applications (NDAs) submitted to the FDA were approved. Few industry professionals have been able match his achievements.