New regulations to protect people participating in medical research issued
On Jan. 27, 1981, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and…
On Jan. 27, 1981, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and…
In 1981, the U.S. Food and Drug Administration (FDA) approved a plasma-derived hepatitis B vaccine for human use….
In 1981, Immunex Corporation was founded by Stephen Duzan, and Christopher Henney and Steven Gillis from the Hutchinson…
In 1981, Imre Corp. (Immune Response Systems, Inc.) was founded in Seattle. The company developed the Prosorba Column,…
In 1980, the Infant Formula Act is one of the most specific and detailed acts ever passed by…
On Jan. 3, 1978, the Yellow fever vaccine (YF-Vax by Connaught) was licensed in the U.S. The Yellow…
In 1978, the U.S. Food and Drug Administration (FDA) approved cisplatin (Platinol) for use in combination with other…
On Jan. 8, 2008, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) had approved Cialis(R)…
On Dec. 30, 1977, the U.S. Food and Drug Administration approved Tamoxifen, an anti-estrogen drug, for the treatment…
On Nov. 23, 1977, the Saccharin Study and Labeling Act was enacted by the U.S. Congress to stop…
On Nov. 21, 1977, the U.S. Food and Drug Administration (FDA) licensed the first pneumococcal vaccine containing 14…
On Apr. 4, 1977, Donald Kennedy, Ph.D., became Commissioner of the U.S. Food and Drug Administration (FDA). Kennedy,…
In 1977, the U.S. Food and Drug Administration (FDA) established the Bioresearch Monitoring Program (BiMo) to develop cross-center…
On Apr. 22, 1976, the U.S. Congress passed the Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic…
In 1976, Influenza A/Victoria-like strains had been identified in New Jersey as early as January 21. The novel…
In 1976, the U.S. Congress passed the Medical Device Amendments to ensure safety and effectiveness of medical devices,…
In 1975, rapamycin, a macrolide produced by the bacterium Streptomyces hygroscopicus was first discovered and isolated from soil…
In Jul. 1974, In the Division of Pharmaceutical Service at the University of Iowa began producing cGMP compliant…
In 1974, the U.S. Food and Drug Administration (FDA) approved doxorubicin (Adriamycin), an antitumor anthracycline antibiotic from Streptomyces…
On Jun. 18, 1973, the U.S. Supreme Court upheld the 1962 drug effectiveness law and endorsed FDA action…
On Oct. 27, 1972, the Consumer Product Safety Commission (CPSA) was enacted by Congress. The CPSA assumed programs…
On Jul. 1, 1972, the Regulation of Biologics–including serums, vaccines, and blood products–was transferred from the NIH to…
In 1972, the Division of Biologics Standards was transferred from NIH to FDA and renamed the Bureau of…
In 1972, the FDA’s new Bureau of Biologics began to regulate all 7000 U.S. blood and plasma centers….
On Sept. 29, 1971, the artificial sweetener saccharin, included in FDA’s original GRAS list, was removed from the…
On May 17, 1971, The Public Health Service’s Bureau of Radiological Health was transferred to the FDA.
In 1971, The PHS Bureau of Radiological Health transferred to FDA. Its mission: protection against unnecessary human exposure…
On Feb. 27, 1970, in Upjohn v. Finch the Court of Appeals upheld enforcement of the 1962 drug…
In 1970, the FDA required the first patient package insert: oral contraceptives must contain information for the patient…
On Dec. 13, 1969, Charles Edwards, M.D., becomes FDA commissioner.