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...thousands of drugs on sale. On 33 other occasions, the pharmaceutical houses have sent out "Dear Doctor" letters to every practicing physician in the country, informing them of misstatements in advertising or other promotional material. Such candor is now compulsory. Under a 1964 law, the FDA adopted various regulations to ensure the accuracy and truthfulness of prescription-drug advertising...
Initially the regulations proved hard to enforce as pharmaceutical producers complied slowly, if at all. When the FDA tried criminal and civil litigation, it found that cases took as long as three years to conclude. Wanting faster service, the FDA switched to "Operation Candor," and required companies whose advertising it found misleading to notify physicians by first-class mail. More recently, the agency began to require remedial advertising, specifying that the corrections must appear in at least two issues of each publication that carried the offending announcement. Of late, this policy has been carried out vigorously...
...ballooned. So has the demand for high-quality acupuncture needles. Last week, however, the Food and Drug Administration temporarily deflated matters. The agency turned back or impounded five consignments of some 200 needles from China on the technicality that they were not properly labeled "medical devices." The FDA'S action may not contribute to the growing rapprochement between the U.S. and China, but it may help protect the American medical consumer. A number of laymen have attempted to cash in on the current American fascination with acupuncture, and many of the needles were destined for those with little training...
...least in part from uncertainty over its legal authority to regulate vaccine potency and how much power HEW could delegate to DBS. A HEW directive seems to have resolved these doubts. A more formal cure is proposed in legislation now before Congress. The bill would combine DBS and FDA into an independent and expanded drug regulatory agency. Meanwhile, health officials would not discuss the charges...
Laetrile, however, is illegal in the United States. The FDA officially holds that sponsors of the drug must simply apply for permission for clinical testing. divestiture cited in the report include the following...