Genentech drug CellCept (mycophenolate mofetil) approved by FDA
On May 3, 1995, the U.S. Food & Drug Administration (FDA) announced it had approved Genentech’s drug CellCept…
FDA declared cigarettes to be “drug delivery devices”
In 1995, the FDA declared cigarettes to be “drug delivery devices.” Restrictions were proposed on marketing and sales…
Biotechnology | CDC | FDA | Infectious Disease | Influenza | Measles | Polio | Vaccine
The ACIP, American Academy of Pediatrics, and the American Association of Family Physicians issued the first “harmonized” childhood immunization schedule
In 1995, the Immunization Practices Advisory Committee (ACIP), American Academy of Pediatrics, and the American Association of Family…
Biotechnology | Diagnostics | FDA | HIV
The FDA approved the first US HIV test system using oral fluid samples
On Dec. 23, 1994, the FDA announced the approval of the first U.S. HIV test system using oral…
Dietary Supplement Health and Education Act established specific labeling requirements for dietary supplements
On Oct. 25. 1994, the Dietary Supplement Health and Education Act was enacted establishing specific labeling requirements, provided…
Animal Medicinal Drug Use Clarification Act allowed veterinarians to prescribe extra-label use of veterinary drugs
On Oct. 22, 1994, the Animal Medicinal Drug Use Clarification Act (AMDUCA) became law permitting veterinarians to prescribe…
The FDA approved the first genetically modified food: the “Flavr Savr” tomato
On May 17, 1994, the U.S. Food and Drug Administration (FDA) approved of the first genetically modified food:…
FDA | Oncology | U.S. Congress
FDA announced it could consider regulating nicotine in cigarettes as a drug
On Feb. 25, 1994, the U.S. Food and Drug Administration (FDA) announced it could consider regulating regulating tobacco…
Rimantadine was approved by the FDA to treat influenza A
In 1994, Rimantadine, derived from amantadine, was approved by the Food and Drug Administration (FDA) to treat influenza…
Biotechnology | Diagnostics | Disease | FDA | Neurology | Ophthalmogy
Omeros Corp was founded
In 1994, Omeros Corp. was founded in Seattle as a biopharmaceutical company committed to discovering, developing and commercializing…
Bristol-Myers Squibb’s PRAVACHOL (pravastatin sodium) granted expanded usage from the FDA
In 1994, Bristol-Myers Squibb’s PRAVACHOL (pravastatin sodium) was granted expanded usage from the U.S. Food and Drug Administration…
Biotechnology | Disease | FDA | Medicine
Genentech drug Pulmozyme (dornase alfa) was approved by the FDA
On Dec. 30, 1993, the Genentech drug Pulmozyme (dornase alfa) was approved by the U.S. Food and Drug…
Biotechnology | FDA | Medicine | Therapeutics
FDA approved Risperidone for use as atypical antipsychotic medication
On Dec. 29, 1993, the U.S. Food and Drug Administration (FDA) approved indications for oral risperidone (tablets, oral…
Genentech drug Nutropin was approved
On Nov. 17, 1993, Genentech drug Nutropin was approved by the U.S. Food and Drug Administration (FDA) for…
FDA granted approval for the sale of the Ahmed Glaucoma Valve
On Nov. 12 ,1993, FDA granted approval for the sale of the Ahmed Glaucoma Valve designed and manufactured…
Biotechnology | Disease | FDA | Therapeutics
FDA approved Betaseron, the first of several biotech products that have had a major impact on multiple sclerosis treatment
On Jul. 23, 1993, the U.S. Food and Drug Administration (FDA) approved Bayer’s Betaseron, the first of several…
Clinical Research | Disease | FDA | IRB | Medicine | Oncology | Therapeutics | Women's Health
FDA issued guidelines calling for improved assessments of medication responses as a function of gender
On Jul. 22, 1993, revising a policy from 1977 that excluded women of childbearing potential from early drug…
Biotechnology | Chemistry | Disease | FDA | Therapeutics
The Earl Davie/ZymoGenetics Endowed Chair of Biochemistry at the University of Washington was established
On Apr. 14, 1993, the Earl Davie/ZymoGenetics Endowed Chair of Biochemistry at the University of Washington was established…
Biotechnology | FDA | Oncology | Therapeutics
The FDA approved Amgen’s Epogen/Procrit for the treatment of anemia
On Apr. 1, 1993, the FDA approved Amgen’s Epogen/Procrit for the treatment of anemia due to the effects…
The FDA approved use of a new haemophilus b conjugate vaccine for infants and children
On Mar. 30, 1993, the U.S. Food and Drug Administration (FDA) approved a new Haemophilus b conjugate vaccine,…
Agriculture | Biotechnology | FDA | U.S. Congress | USDA
FDA declared genetically-engineered foods are not inherently dangerous and do not require special regulation
In 1993, the U.S. Food and Drug Administration (FDA) declared genetically-engineered foods are not inherently dangerous and do…
FDA added new CBER reviewers to streamline biologics review and user fees were enacted
In 1993, The U.S. Food and Drug Administration (FDA) added new CBER reviewers to streamline biologics review. User…
Biotechnology | Disease | FDA | Forestry | Oncology | Therapeutics | Women's Health
Taxol (paclitaxel) approved by the FDA for the treatment of ovarian cancer that has failed other therapy
On Dec. 18, 1992, Taxol (paclitaxel), an anticancer drug extracted from the bark of the Pacific yew, received…
Biotechnology | FDA | Infectious Disease | Therapeutics | Vaccine | WHO
Japanese encephalitis virus vaccine inactivated was licensed
On Dec. 10, 1992, the Japanese encephalitis (JE) virus vaccine inactivated (JE-Vax by Research Foundation for Microbial Diseases…
Diagnostics | FDA | NIH | Oncology | Radiology | U.S. Congress | Women's Health
The Mammography Quality Standards Act was passed by the US Congress
On Oct. 27, 1992, the Mammography Quality Standards Act (MQSA) was passed (P.L. 102-539) by the U.S. Congress…
PathoGenesis was founded
On Sept. 3, 1992, PathoGenesis Corp. was founded by Robert Nowinski. The company, based in Seattle, developed an…
Agriculture | Biotechnology | FDA | USDA
FDA announced new food labeling rules
On Feb. 29, 1992, the U.S. Food and Drug Administration (FDA) announced new food labeling rules. The purpose…
Prescription Drug User Fee Act required drug and biologics manufacturers to pay fees for product applications, and other services
In 1992, President George Bush signed the Prescription Drug User Fee Act (PDUFA) and under the Clinton administration,…
University of Iowa Research Foundation received U.S. patents for CMV promoter
In 1992, the University of Iowa (UI) Research Foundation received its first U.S. patent on the CMV promoter,…
Diphtheria and tetanus toxoids and acellular pertussis vaccine was licensed for use
On Dec. 17, 1991, the Diphtheria and tetanus toxoids and acellular pertussis vaccine (Acel-Imune by Lederle) was licensed…