Mission 3: Developing a Regulatory Strategy – By Karl A. Traul, Ph.D

In recent news and in articles in this Newsletter, we have read about the apparent slowdown of the approval process for new products being reviewed by the Food and Drug Administration (FDA). While part of this has been attributed to the increasing complexity of the biological and biomedical sciences being applied to new products, I believe that part is attributable to inadequate or incomplete regulatory planning.

FDA is tasked with the responsibility of assuring, to the best of its ability, that products under its regulatory authority are safe and effective before they are marketed in the U.S. In general terminology, FDA regulates “anything that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” in man or animals. The authority covers drugs, biologicals, vaccines and medical devices and the authority extends to certain foods, food additives, food packaging and cosmetics. Many products of the burgeoning biotechnology efforts are included in the agency’s authority. The agency is developing guidance for follow-on (generic) biologicals and is under increasing pressure to regulate nutraceuticals, cosmeceuticals and homeopathic and herbal medicines, many of which are available over the counter without regulation.

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