WASHINGTON--The U.S. Food and Drug Administration has been taking its lumps of late for its failure to adequately monitor the generic drug review process. FDA officials, in defending themselves before congressional inquiries, say that financial limitations—on staff and other resources—have hampered the agency’s ability to perform its statutory duties. But it seems that FDA has made its job of regulating the nation’s pharmaceutical industry more difficult by failing to

Ask Carl C. Peck of the Food and Drug Administration how important research is to his job, and he’ll simply point to the title of the center he heads. 

WASHINGTON—The recent censure of Charles J. Glueck for misreporting his studies of children on low-cholesterol diets illustrates the biomedical community’s increasing concern about scientific misconduct, according to NIH Deputy Director William Raub. Glueck, who has received several NIH grants, was formally censured by the agency last month. It has recommended that Glueck be barred from receiving any federal funds for two years, and banned from serving on any government advisory g

WASHINGTON—The Food and Drug Administration has given final approval to a set of regulations that will give some patients with immediate life-threatening diseases quicker access to experimental drugs. The rules have been revised in an attempt to allay scientists' fears that such a "fast track" would abandon traditional safety requirements and jeopardize clinical trials, and drug companies' concerns that it might prolong the process of gaining final approval. Yet the final rules may not hav

WASHINGTON—Two and a half years after a presidential veto of the concept, Lawrence Shulman is taking charge as director of the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS). "There's a lot to do," said Shulman about the 12th and newest institute on the NIH campus, carved out of an existing institute after Congress voted in 1985 to override the Reagan veto. "And Congress has told us to do it." Shulman, 67, joined the NIH a decade ago from Johns Hopkins Univers