The Hatch-Waxman Act was passed to encourage development of generic prescription drugs
On Sept. 24, 1984 the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act) was passed to…
Tamper-resistant Packing Regulations issued by FDA
On Nov. 5, 1982, the U.S. Food and Drug Administration (FDA) published requirements of the tamper-resistant packaging (TRP)…
Biotechnology | Disease | FDA | Therapeutics
The first biotech drug, human insulin produced in genetically modified bacteria, was approved by FDA
On Oct. 28, 1982, the U.S. Food and Drug Administration (FDA) approved Humulin, Eli Lily’s recombinant insulin made…
Johnson & Johnson, the parent company of McNeil, issued a nationwide recall of Tylenol products
On Oct. 5, 1982, Johnson & Johnson, the parent company of McNeil, issued a nationwide recall of Tylenol…
The first of seven victims died after taking a capsule of Extra-Strength Tylenol
On Sept. 29, 1982. the first of seven victims died after taking a capsule of Extra-Strength Tylenol. On…
CDC | FDA | HIV | NIH | Therapeutics
The second AIDS patient seen at NIH was admitted to the National Institute of Allergy and Infectious Diseases service
On Jan. 15, 1982, the second AIDS patient was admitted to the National Institute of Allergy and Infectious…
University of Washington scientists created first “transgenic mouse”
In 1982, Richard D. Palmiter at the University of Washington scientists created first “transgenic mouse” in collaboration with…
FDA published the first Red Book (successor to 1949 “black book”)
In 1982, the U.S. Food and Drug Administration issued a publication, known as the Redbook, that described the…
Quadrivalent groups A, C, Y, and W-135 (Menomune A/C/Y/W-135 by Connaught) meningococcal vaccine was licensed
On Nov. 23, 1981, the U.S. Food and Drug Administration licensed Quadrivalent groups A, C, Y, and W-135…
FDA approved vinblastine, a drug that binds to tubulin, a key player in cell division
On Jul. 2, 1981, the FDA approved vinblastine, a drug that binds to tubulin, the protein building block…
Biotechnology | Diagnostics | Disease | FDA | Medical Device | Medicine | Pharmaceutical | Therapeutics
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…
First human viral vaccine to prevent cancer (hepatitis B vaccine for liver cancer) was introduced
In 1981, the U.S. Food and Drug Administration (FDA) approved a plasma-derived hepatitis B vaccine for human use….
Immunex Corporation was founded
In 1981, Immunex Corporation was founded by Stephen Duzan, and Christopher Henney and Steven Gillis from the Hutchinson…
Biotechnology | Disease | FDA | Therapeutics
Imre Corp was founded
In 1981, Imre Corp. (Immune Response Systems, Inc.) was founded in Seattle. The company developed the Prosorba Column,…
Infant Formula Act established special FDA controls to ensure necessary nutritional content and safety
In 1980, the Infant Formula Act is one of the most specific and detailed acts ever passed by…
Biology | Diagnostics | Disease | FDA | Life Science History | Non-Profit Research | Oncology | Therapeutics
FDA approved Cisplatin, a platinum-containing anticancer compound
On Dec. 19, 1978, the U.S. Food and Drug Administration (FDA) approved cisplatin (Platinol) for use in combination…
Yellow fever vaccine (YF-Vax by Connaught) was licensed in the U.S.
On Jan. 3, 1978, the Yellow fever vaccine (YF-Vax by Connaught) was licensed in the U.S. The Yellow…
FDA Approved Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction
On Jan. 8, 2008, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) had approved Cialis(R)…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics | Women's Health
Tamoxifen was approved by the FDA for the treatment of breast cancer
On Dec. 30, 1977, the U.S. Food and Drug Administration approved Tamoxifen, an anti-estrogen drug, for the treatment…
Saccharin Study and Labeling Act passed by Congress to stop FDA from banning the chemical sweetener
On Nov. 23, 1977, the Saccharin Study and Labeling Act was enacted by the U.S. Congress to stop…
The first pneumococcal vaccine was licensed
On Nov. 21, 1977, the U.S. Food and Drug Administration (FDA) licensed the first pneumococcal vaccine containing 14…
Donald Kennedy, Ph.D., became Commissioner of Food and Drugs
On Apr. 4, 1977, Donald Kennedy, Ph.D., became Commissioner of the U.S. Food and Drug Administration (FDA). Kennedy,…
The U.S. FDA Bioresearch Monitoring Program was introduced
In 1977, the U.S. Food and Drug Administration (FDA) established the Bioresearch Monitoring Program (BiMo) to develop cross-center…
Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic Act was passed
On Apr. 22, 1976, the U.S. Congress passed the Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic…
Biotechnology | CDC | Diagnostics | FDA | Influenza | Life Science History | Therapeutics | Vaccine
H1N1 outbreak at Fort Dix lead to a vaccination program to prevent a pandemic
In 1976, Influenza A/Victoria-like strains had been identified in New Jersey as early as January 21. The novel…
U.S. Congress passed Medical Device Amendments to ensure safety and effectiveness of medical devices
In 1976, the U.S. Congress passed the Medical Device Amendments to ensure safety and effectiveness of medical devices,…
Rapamcyin, an immune suppression drug, was isolated from a soil sample from Easter Island
In 1975, rapamycin, a macrolide produced by the bacterium Streptomyces hygroscopicus was first discovered and isolated from soil…
University of Iowa began pharmaceutical production
In Jul. 1974, In the Division of Pharmaceutical Service at the University of Iowa began producing cGMP compliant…
The FDA approved doxorubicin (Adriamycin)
In 1974, the U.S. Food and Drug Administration (FDA) approved doxorubicin (Adriamycin), an antitumor anthracycline antibiotic from Streptomyces…
U.S. Supreme Court upheld 1962 drug effectiveness law and endorsed FDA action to control products by regulation
On Jun. 18, 1973, the U.S. Supreme Court upheld the 1962 drug effectiveness law and endorsed Food and…