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Home / FDA - Page 37

FDA

FDA approved Protein-conjugated Haemophilus influenzae type b vaccine (PRP-D, ProHibit by Connaught)
Biotechnology | FDA | Infectious Disease | Influenza | Vaccine

FDA approved Protein-conjugated Haemophilus influenzae type b vaccine (PRP-D, ProHibit by Connaught)

On Dec. 22, 1987, the protein-conjugated Haemophilus influenzae type b vaccine (PRP-D, ProHibit by Connaught) was licensed.

Read More FDA approved Protein-conjugated Haemophilus influenzae type b vaccine (PRP-D, ProHibit by Connaught)Continue

The antidepressant fluoxetine (Prozac), discovered by David T. Wong, was given FDA approval
Biotechnology | FDA | Neurology | Therapeutics

The antidepressant fluoxetine (Prozac), discovered by David T. Wong, was given FDA approval

In December 1987, the antidepressant fluoxetine (Prozac), discovered by David T. Wong, received U.S. Food and Drug Administration…

Read More The antidepressant fluoxetine (Prozac), discovered by David T. Wong, was given FDA approvalContinue

The Center for Biologics Evaluation and Research was created within the FDA
Biotechnology | FDA | Medical Device | Therapeutics

The Center for Biologics Evaluation and Research was created within the FDA

On Oct. 6, 1987, the Center for Drugs and Biologics within the U.S. Food and Drug Administration was…

Read More The Center for Biologics Evaluation and Research was created within the FDAContinue

Advanced Genetic Sciences announced Frostban bacteria successfully protected strawberries from below-freezing temperatures
Agriculture | Biotechnology | FDA | USDA

Advanced Genetic Sciences announced Frostban bacteria successfully protected strawberries from below-freezing temperatures

On Jun. 8, 1987, Advanced Genetic Sciences announced that its Frostban (Ice-minus) bacteria successfully protected strawberries from below-freezing…

Read More Advanced Genetic Sciences announced Frostban bacteria successfully protected strawberries from below-freezing temperaturesContinue

Investigational drug regulations revised to expand access to experimental drugs for patients with no alternative therapies
Biotechnology | FDA | Pharmaceutical | Rare Disease | Therapeutics

Investigational drug regulations revised to expand access to experimental drugs for patients with no alternative therapies

In 1987, the U.S. Food and Drug Administration (FDA) announced revised regulations regarding Expanded Access (EA) to investigational…

Read More Investigational drug regulations revised to expand access to experimental drugs for patients with no alternative therapiesContinue

The FDA approved first Western blot blood test more specific HIV diagnostic test and AZT as the first antiretroviral drug to be used as a treatment for AIDS
Biotechnology | FDA | HIV | Therapeutics

The FDA approved first Western blot blood test more specific HIV diagnostic test and AZT as the first antiretroviral drug to be used as a treatment for AIDS

In 1987, the FDA approved first Western blot blood test more specific HIV diagnostic test and AZT as…

Read More The FDA approved first Western blot blood test more specific HIV diagnostic test and AZT as the first antiretroviral drug to be used as a treatment for AIDSContinue

Genentech drug Activase (alteplase) was approved
Biotechnology | FDA | Therapeutics

Genentech drug Activase (alteplase) was approved

In 1987, the U.S. Food and Drug Administration (FDA) approved Genentech’s drug tPA Activase (alteplase).  Activase is a…

Read More Genentech drug Activase (alteplase) was approvedContinue

President Reagan signed the Anti-Drug Abuse Act of 1986, which outlawed the sale of steroids for non-medical purposes
FDA | Medicine | U.S. Congress

President Reagan signed the Anti-Drug Abuse Act of 1986, which outlawed the sale of steroids for non-medical purposes

On Oct. 27, 1986, President Ronald Reagan signed the the Anti-Drug Abuse Act of 1986.  The Act changed…

Read More President Reagan signed the Anti-Drug Abuse Act of 1986, which outlawed the sale of steroids for non-medical purposesContinue

Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, died after living 620 days
Disease | FDA | Medical Device | Therapeutics

Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, died after living 620 days

On Aug. 6, 1986, Bill Schroeder from Jasper, Indiana, the second human recipient of the Jarvik 7 artificial…

Read More Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, died after living 620 daysContinue

Interferon became the first anticancer drug produced through biotechnology
Biotechnology | FDA | Oncology | Therapeutics

Interferon became the first anticancer drug produced through biotechnology

On Jun. 5, 1986, the U.S. Food and Drug Administration (FDA) approved Hoffmann La Roche’s Interferon  initially for…

Read More Interferon became the first anticancer drug produced through biotechnologyContinue

The first recombinant vaccine for humans, a vaccine for hepatitis B, was approved
Biotechnology | FDA | Life Science History | Therapeutics

The first recombinant vaccine for humans, a vaccine for hepatitis B, was approved

In May 1986, the vaccine Recombivax HB, which protects against hepatitis B infection, was approved for marketing in…

Read More The first recombinant vaccine for humans, a vaccine for hepatitis B, was approvedContinue

Procyte Corp. was founded
FDA | Life Science History

Procyte Corp. was founded

In 1986, Procyte Corp. was founded as a Kirkland, Washington-based medical skin care company that developed and marketed…

Read More Procyte Corp. was foundedContinue

First clinical tests conducted at UW of EPO to correct anemia of kidney failure
Disease | FDA | Life Science History | Therapeutics

First clinical tests conducted at UW of EPO to correct anemia of kidney failure

In Dec. 1985, the first clinical tests were held at the University of Washington of erythropoietin (EPO), the…

Read More First clinical tests conducted at UW of EPO to correct anemia of kidney failureContinue

The Health Research Extension Act of 1985 (PL 99-158) was signed into law
Biotechnology | Diagnostics | Disease | FDA | Medicine | Therapeutics | U.S. Congress | Veterinary

The Health Research Extension Act of 1985 (PL 99-158) was signed into law

On Nov. 20, 1985, the Health Research Extension Act of 1985 (P.L. 99-158) was signed into law by…

Read More The Health Research Extension Act of 1985 (PL 99-158) was signed into lawContinue

FDA approved human growth hormone
Biotechnology | Disease | FDA | Therapeutics

FDA approved human growth hormone

On Oct. 18, 1985, Genentech received U.S. Food and Drug Administration (FDA) approval of its first medicine, Protropin…

Read More FDA approved human growth hormoneContinue

Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, was discharged from the hospital
Disease | FDA | Medical Device | Therapeutics

Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, was discharged from the hospital

On Apr. 6, 1985, Bill Schroeder from Jasper, Indiana, the second human recipient of the Jarvik 7 artificial…

Read More Bill Schroeder, the second human recipient of the Jarvik 7 artificial heart, was discharged from the hospitalContinue

Red Cross Blood Services began testing all newly donated blood with the first HIV detection test
Biotechnology | Diagnostics | FDA | HIV

Red Cross Blood Services began testing all newly donated blood with the first HIV detection test

On Mar. 4, 1985, the Red Cross Blood Services began testing all newly donated blood with the first…

Read More Red Cross Blood Services began testing all newly donated blood with the first HIV detection testContinue

The FDA approved the first test for HIV antbody screening of blood donors
Biotechnology | FDA | HIV

The FDA approved the first test for HIV antbody screening of blood donors

On Mar. 2, 1985, the FDA announced the approval of the Abbott first antibody test kit to screen…

Read More The FDA approved the first test for HIV antbody screening of blood donorsContinue

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, after only 5 months of review, the U.S. Food and Drug Administration (FDA) approved…

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…

Read More FDA published the first Red Book (successor to 1949 “black book”)Continue

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…

Read More New regulations to protect people participating in medical research issuedContinue

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

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