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Home / FDA - Page 37

FDA

The Hatch-Waxman Act was passed to encourage development of generic prescription drugs
FDA | Pharmaceutical

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…

Read More The Hatch-Waxman Act was passed to encourage development of generic prescription drugsContinue

Tamper-resistant Packing Regulations issued by FDA
Biotechnology | FDA | Pharmaceutical | U.S. Congress

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)…

Read More Tamper-resistant Packing Regulations issued by FDAContinue

The first biotech drug, human insulin produced in genetically modified bacteria, was approved by FDA
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…

Read More The first biotech drug, human insulin produced in genetically modified bacteria, was approved by FDAContinue

Johnson & Johnson, the parent company of McNeil, issued a nationwide recall of Tylenol products
Diagnostics | FDA | Pharmaceutical

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…

Read More Johnson & Johnson, the parent company of McNeil, issued a nationwide recall of Tylenol productsContinue

The first of seven victims died after taking a capsule of Extra-Strength Tylenol
Diagnostics | FDA | Pharmaceutical

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…

Read More The first of seven victims died after taking a capsule of Extra-Strength TylenolContinue

The second AIDS patient seen at NIH was admitted to the National Institute of Allergy and Infectious Diseases service
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…

Read More The second AIDS patient seen at NIH was admitted to the National Institute of Allergy and Infectious Diseases serviceContinue

University of Washington scientists created first “transgenic mouse”
Biotechnology | Diagnostics | Disease | FDA | Non-Profit Research | Therapeutics | Veterinary

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…

Read More University of Washington scientists created first “transgenic mouse”Continue

FDA published the first Red Book (successor to 1949 “black book”)
Biotechnology | Diagnostics | FDA | Medical Device | Therapeutics

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…

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Quadrivalent groups A, C, Y, and W-135 (Menomune A/C/Y/W-135 by Connaught) meningococcal vaccine was licensed
Biotechnology | FDA | Infectious Disease | Neurology | Vaccine

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…

Read More Quadrivalent groups A, C, Y, and W-135 (Menomune A/C/Y/W-135 by Connaught) meningococcal vaccine was licensedContinue

FDA approved vinblastine, a drug that binds to tubulin, a key player in cell division
FDA | Life Science History

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…

Read More FDA approved vinblastine, a drug that binds to tubulin, a key player in cell divisionContinue

New regulations to protect people participating in medical research issued
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…

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First human viral vaccine to prevent cancer (hepatitis B vaccine for liver cancer) was introduced
Biotechnology | FDA | Infectious Disease | Vaccine

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….

Read More First human viral vaccine to prevent cancer (hepatitis B vaccine for liver cancer) was introducedContinue

Immunex Corporation was founded
Biotechnology | FDA | Therapeutics

Immunex Corporation was founded

In 1981, Immunex Corporation was founded by Stephen Duzan, and Christopher Henney and Steven Gillis from the Hutchinson…

Read More Immunex Corporation was foundedContinue

Imre Corp was founded
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,…

Read More Imre Corp was foundedContinue

Infant Formula Act established special FDA controls to ensure necessary nutritional content and safety
Biotechnology | FDA | U.S. Congress

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…

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FDA approved Cisplatin, a platinum-containing anticancer compound
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…

Read More FDA approved Cisplatin, a platinum-containing anticancer compoundContinue

Yellow fever vaccine (YF-Vax by Connaught) was licensed in the U.S.
FDA | Infectious Disease | Life Science History | Vaccine

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…

Read More Yellow fever vaccine (YF-Vax by Connaught) was licensed in the U.S.Continue

FDA Approved Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction
Biotechnology | FDA | Pharmaceutical

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)…

Read More FDA Approved Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile DysfunctionContinue

Tamoxifen was approved by the FDA for the treatment of breast cancer
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…

Read More Tamoxifen was approved by the FDA for the treatment of breast cancerContinue

Saccharin Study and Labeling Act passed by Congress to stop FDA from banning the chemical sweetener
Chemical | FDA | Life Science History | U.S. Congress

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…

Read More Saccharin Study and Labeling Act passed by Congress to stop FDA from banning the chemical sweetenerContinue

The first pneumococcal vaccine was licensed
FDA | Infectious Disease | Vaccine

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…

Read More The first pneumococcal vaccine was licensedContinue

Donald Kennedy, Ph.D., became Commissioner of Food and Drugs
FDA | Life Science History

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,…

Read More Donald Kennedy, Ph.D., became Commissioner of Food and DrugsContinue

The U.S. FDA Bioresearch Monitoring Program was introduced
Biotechnology | FDA | Life Science History | Therapeutics

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…

Read More The U.S. FDA Bioresearch Monitoring Program was introducedContinue

Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic Act was passed
FDA | Life Science History | U.S. Congress

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…

Read More Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic Act was passedContinue

H1N1 outbreak at Fort Dix lead to a vaccination program to prevent a pandemic
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…

Read More H1N1 outbreak at Fort Dix lead to a vaccination program to prevent a pandemicContinue

U.S. Congress passed Medical Device Amendments to ensure safety and effectiveness of medical devices
Diagnostics | FDA | Life Science History | Medical Device | Therapeutics | U.S. Congress

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,…

Read More U.S. Congress passed Medical Device Amendments to ensure safety and effectiveness of medical devicesContinue

Rapamcyin, an immune suppression drug, was isolated from a soil sample from Easter Island
FDA | Life Science History | Medicine | Therapeutics

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…

Read More Rapamcyin, an immune suppression drug, was isolated from a soil sample from Easter IslandContinue

University of Iowa began pharmaceutical production
Biotechnology | CMO | FDA | Life Science History | Non-Profit Research | Pharmaceutical

University of Iowa began pharmaceutical production

In Jul. 1974, In the Division of Pharmaceutical Service at the University of Iowa began producing cGMP compliant…

Read More University of Iowa began pharmaceutical productionContinue

The FDA approved doxorubicin (Adriamycin)
FDA | Life Science History | Oncology | Therapeutics

The FDA approved doxorubicin (Adriamycin)

In 1974, the U.S. Food and Drug Administration (FDA) approved doxorubicin (Adriamycin), an antitumor anthracycline antibiotic from Streptomyces…

Read More The FDA approved doxorubicin (Adriamycin)Continue

U.S. Supreme Court upheld 1962 drug effectiveness law and endorsed FDA action to control products by regulation
FDA | Life Science History | Medicine | Pharmaceutical | Therapeutics | U.S. Congress

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…

Read More U.S. Supreme Court upheld 1962 drug effectiveness law and endorsed FDA action to control products by regulationContinue

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