Word: fda
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...some danger that the injections may promote the growth of ovarian cysts, and have other harmful side effects. Nobody is preparing the pituitary extract for general use. Cutter Laboratories of Berkeley, Calif., has sole rights to make and market Pergonal in the U.S., but it will take the FDA months or years to decide whether the drug should be cleared for general use. Meanwhile, the fertility research centers are booked solid for all available supplies, and they cannot take care of any more patients...
...congressional investigation of the industry by the late Senator Estes Kefauver and the scandal of thalidomide caused birth defects have led Congress to give the Food and Drug Administration broader powers to police the research, manufacture and testing of drugs. Previously, drug companies were not required to consult the FDA on a new drug until they were ready for final market clearance. Now the FDA supervises every step of testing, and the companies complain that it costs extra time and money to get a drug approved...
...brand-name products. Compounding the industry's frustration is the fact that, despite steady increases in research budgets, fewer than 20 new basic drugs will be introduced this year compared with 45 in 1960; the reasons lie more in the erratic nature of research than in any FDA delays...
Winton B. Rankin, an FDA spokesman, told a special Senate subcommittee that the agency had found no evidence that such impurities are to blame; for safety's sake the FDA is continuing its investigation. There is no doubt, however, that some wearers of contact lenses suffer eye damage from other causes. Explained Rankin: "It appears that the principal difficulty arises from improper fitting, insanitary practices by the wearer, or wearing the lenses too long at a time." On that, optometrists and ophthalmologists, who have differed sharply over the fitting of contacts, were for once in agreement...
Last week the Merrell Co. was on trial with three of its former executives and parent Richardson-Merrell Inc. on twelve counts of supplying FDA with "false, fictious and fraudulent" data. After first pleading not guilty, the companies and the executives switched their pleas to nolo contendere (no contest) on eight counts. After Federal Judge Matthew M. McGuire made sure that each defendant understood that the new plea was "tantamount to a plea of guilty," the Justice Department dropped the four remaining counts. It is now up to Judge McGuire to fix the sentences. For the companies, fines could total...