given the Elixir Sulfanilamide
incident, this pre-market notification
The 1937 Elixir Sulfanilamide
Incident, 15 FDA CONSUMER 18 (1981), available at http://www.
While there, he experimented with dyes as antibiotics and discovered that a dye component, sulfanilamide
, killed strep and tuberculosis bacteria.
was released in the US in 1936, when safety and efficacy studies were not required; the sole FDA requirement was that the product label list all active ingredients.
The next big change was the discovery of anti-infectives, sulfanilamide
in 1935 and penicillin in 1940.
Standard solutions of N-(1-naphthyl) ethylenediamine dihydrochloride (NED), sulfanilamide
, glycine, L-aspartic acid, sodium nitrite, urea, ethylenediaminetetraacetic acid disodium salt (EDTA), ammonium chloride, L-glutamic acid sodium salt and L-arginine, each containing 5 mg N/L, were used to determine N recovery (against KN[O.
This philosophy emerged after drug disasters such as those involving elixer sulfanilamide
and thalidomide revealed the harm that could come from inadequate government controls.
They often mention a 1901 diphtheria outbreak in which thirteen children died from a flawed remedy or the "Elixir Sulfanilamide
tragedy" of the 1930s (out of which the Food, Drug, and Cosmetic Act was born) in which more than one hundred people, most of them children, died.
Gonococcal resistance has been ongoing since the 1940s, starting with resistance to sulfanilamide
After a long legislative fight, the Act was signed into law following public awareness of the tragedy surrounding sulfanilamide
Phototoxic photosensitivity: tetracyclines, sulfanilamide
, chlorpromazine, psoralens
82) In 1941, the year that Roosevelt issued the first executive order prohibiting discrimination on grounds of race, color, creed, or nationality in federal contracts, (83) doctors successfully treated trachoma and pneumonia with sulfanilamide
, and Cheerios appeared for the first time on American breakfast tables.