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June 1961

The Doctor's Dilemma—Drug Therapy and the Facts of Life

Arch Intern Med. 1961;107(6):810-812. doi:10.1001/archinte.1961.03620060010004

Probably in no country in the world does the potency and purity of drugs correspond as strictly with the claims of the manufacturers as in the United States. Multiple safeguards are set up for the protection of the public. After the research departments of the various drug and biological houses have produced what they consider a useful and safe drug, it is submitted to the Food and Drug Administration where the protocols supporting the claims are examined. In the cases of antibacterial drugs the manufacturers usually carry on what clinical trials their access to patients will permit and at the same time send out many batches of the new drug to clinical investigators throughout the country. Usually the results of the pharmacological studies and the clinical trials by physicians form the basis for the final decision regarding permission to market the new product.

If in vitro bacterial sensitivity tests indicate

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