Word: fda
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...twelve years: Is there any basis for the claims that Krebiozen, a mysterious horse-serum drug, is a cure for some forms of cancer? Though Krebiozen has never been approved by any federal agency, about 3,500 doctors have given it to about 5,000 patients. Last week FDA began gathering evidence to establish...
...Whether it can qualify for sale under an FDA license...
...source reported the FBI and FDA officials were very interested in reports of the illegal sale of drugs in Cambridge, and were anxious to apprehend any persons guilty of violating federal drug laws...
...Regulations. Ironically, there is nothing in the new law that could with certainty prevent a repetition of the thalidomide disaster. But while the bill was working its way to the White House, FDA drew up a set of new regulations (under its old-law powers) to give it tighter control of drug testing in man. Not yet formally approved and still subject to detailed amendment, these proposals require that a physician who wants to try a still unapproved drug on his patients must register with FDA, submit evidence of his qualifications, and keep full and accurate records...
...point where doctors nnd drug makers had been at odds with FDA men and many legislators, a sensible compomise was reached. Extremists crying "Human guinea pig!" had demanded that no doctor be allowed to give an investigational drug to a patient without telling him so. This would have made it impossible to compare the effects of a drug with those of an inert dummy (a placebo), as is now done in "double-blind" studies in which neither doctors nor patients know who is getting the active substance. So the law now says that doctors must tell patients what they...