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The Best Fda Regulatory Affairs - January 2021

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Lawrence T. Friedhoff

About the Writer:

Throughout his 30-year profession in pharmaceutical development and research, author Lawrence T. Friedhoff, MD, PhD, FACP has gathered an extraordinary list of industry accomplishments, most especially since the head of the groups that chose, developed, and brought two chemical substances through regulatory areas around the world. These new drugs are market "blockbusters," each used by millions of individuals and every generating well over $1 billion yearly revenue worldwide. Dr. Friedhoff's firsthand understanding of pharmaceutical R&D is comprehensive and extensive: he's held management positions in multinational businesses developing innovative drug compounds, little publicly-traded companies producing generic medications, start-up ventures, along with academic-based research teams writing business plans to acquire venture capital. As an R&D head, he also held primary responsibility for selecting drug candidates and preparing detailed plans for, in addition to handling all phases of, their advancement, always with an eye towards satisfying FDA (and frequently, European and Asian) drug requirements. He has handled activities such as collecting and assessing information from consumers, fielding queries from patients and healthcare providers, and scientific research. Even though the media includes numerous reports of catastrophic failed clinical trials, even during Dr. Friedhoff's career none of the finished critical clinical trials for which he had been fully responsible ever failed and all of his brand new drug applications (NDAs) filed to the FDA were approved. Industry professionals have managed match his achievements.

Dr. Friedhoff has acquired several patents and continues to be a frequent and off-cited contributor to the scientific literature. He is also the founder of Pharmaceutical Special Projects Group, LLC, a consortium of independent consultants a

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