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Each year in the United States, 1.6 billion new and renewal prescriptions for drugs—approximately eight per person—are written, says Gerald A. Faich, MD, director of the FDA's Office of Epidemiology and Biostatistics. Most of these prescriptions are for older, established drugs, but about 20 new chemical entities come into the marketplace annually.
"People must understand that everything that goes into the multimillion dollar package of getting a drug through FDA approval cannot be totally complete," Faich emphasizes. "Clinical trials go on for only a couple of years; there are inherent limitations [on time, size, cost, and inclusion of other complicating factors]. Once a drug is on the market, that's where we come in. Our task is postmarketing surveillance, and our division [of the Center for Drugs and Biologics] is probably the one with which physicians are likely to be in contact."
"We know that most of what we're going to
Goldsmith MF. Postmarketing follow-up: physicians have key role. JAMA. 1985;254(16):2217–2221. doi:10.1001/jama.1985.03360160045008
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