FDA published “Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New Medical Products”
In 2004, the FDA published “Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New…
The Emergency Use Authorization program was established
In 2004, the Emergency Use Authorization (EUA) program was established in 2004, when the Project BioShield Act, among…
Biotechnology | Diagnostics | FDA | NIH | Oncology | Therapeutics
The National Cancer Institute collaborated with the Department of Health and Human Services to establish National Network of Tobacco Cessation Quitlines
In 2004, the National Cancer Institute (NCI) collaborated with the Department of Health and Human Services to establish…
Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility
In 2004, the Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility, the first built in partnership…
FDA issued public health advisory urging health professionals to limit the use of Cox-2 selective agents
In 2004, Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) because of an increased risk of heart…
Cialis was approved by the FDA
On Nov. 21, 2003, Cialis (tadalafil), discovered through a Glaxo Wellcome and ICOS Corp. partnership, was approved by…
The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors
On Nov. 18, 2003, the U.S. Congress passed the Animal Drug User Fee Act (ADUFA) which permitted the…
An obesity working group is established by the Commissioner of Food and Drugs
On Oct. 8, 2003, an obesity working group was established by the Commissioner of Food and Drugs, charged…
FDA approved an expanded indication for ENBREL (etanercept) to inhibit progression of structural damage of active arthritis
On Aug. 25, 2003, the FDA approved an expanded indication for ENBREL (etanercept) to inhibit the progression of…
The FDA announced food labels to include trans fat content
On Jul. 11, 2003, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal…
Biotechnology | Disease | FDA | Therapeutics
Genentech drug Xolair (omalizumab) was approved
On Jun. 20, 2003, Genentech drug Xolair (omalizumab) was approved by the U. S. Food and Drug Administration…
The FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma
On May 13, 2003, the FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma. In…
Agriculture | Biotechnology | FDA | USDA
The National Academy of Sciences released “Scientific Criteria to Ensure Safe Food”
On Apr. 7, 2003, the National Academy of Sciences released “Scientific Criteria to Ensure Safe Food,” a report…
Biotechnology | Disease | FDA | Medicine | Therapeutics
Long-term efficacy and safety of etanercept was found in children with polyarticular-course juvenile rheumatoid arthritis
On Jan. 10, 2003, long-term efficacy and safety of etanercept (Enbrel) was found in children with polyarticular-course juvenile…
Two randomized controlled trials showed that taking aspirin daily for as little as three years reduces the development of colorectal polyps
In 2003, two randomized controlled trials showed that taking aspirin daily for as little as three years reduces…
The FDA Office of Combination Products was formed
On Dec. 24, 2002, the FDA’s Office of Combination Products was formed within the Office of the Commissioner,…
FDA | Infectious Disease | Polio | Vaccine
Vaccine that combined diphtheria, tetanus, acellular pertussis, inactivated polio and hepatitis B antigens was licensed
On Dec. 13, 2002, the U.S. Food and Drug Administration (FDA) announced it had licensed a combined diphtheria…
Biotechnology | Disease | FDA
Genentech drug Pegasys (peginterferon alfa-2a) approved
On Dec. 3, 2002, Genentech drug Pegasys (peginterferon alfa-2a) was approved by the Food and Drug Administration (FDA)…
NCI and FDA scientists reported patterns of proteins found in patients’ blood can distinguish between prostate cancer and benign conditions
On Oct. 16, 2002, patterns of proteins found in patients’ blood may help distinguish between prostate cancer and…
FDA announced initiative to modernize the regulation of pharmaceutical manufacturing
On Aug. 21, 2002, the FDA announced an initiative to modernize the regulation of pharmaceutical manufacturing and product…
The FDA announced the current good manufacturing practice (cGMP) initiative
On Aug. 21, 2002, the FDA announced an effort to enhance and update the regulation of manufacturing processes…
Biotechnology | FDA | Oncology | Therapeutics
FDA approved Amgen’s aranesp for anemia associated with chemotherapy
On Jul. 22, 2002, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved Aranesp (darbepoetin…
Immunex Corp. was acquired by Amgen
On Jul. 16, 2002, Amgen completed it’s acquisition of Immunex Corporation for $16 billion in stock and net…
Biotechnology | Diagnostics | FDA | Infectious Disease | Medicine | NIH | Plague | Radiology | Therapeutics | U.S. Congress
President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into law
On Jun. 12, 2002, President George W. Bush signed the Public Health Security and Bioterrorism Preparedness and Response…
Diphtheria and tetanus toxoids and acellular pertussis vaccine (Daptacel by Aventis Pasteur) was licensed
On May 14, 2002, the Food and Drug Administration (FDA) approved for use an additional combined diphtheria and…
BOTOX(R) cosmetic (onabotulinumtoxinA) approved by the FDA
On Apr. 15, 2002, BOTOX(R) cosmetic (onabotulinumtoxinA), manufactured by Allergan, was approved by the Food and Drug Administration…
The FDA approved the first nucleic acid test system to screen whole blood donors for infections with HIV and HCV
On Feb. 28, 2002, the FDA announced it had licensed the first nucleic acid test (NAT) system intended…
Scientists from NCI and FDA reported that patterns of proteins found in patients’ serum may reflect the presence of ovarian cancer
On Feb. 7, 2002, scientists from the National Cancer Institute (NCI) and the Food and Drug Administration (FDA)…
FDA approved Gleevec for gastrointestinal stromal tumors treatment
On Feb. 1, 2002, the U.S. Food and Drug Administration (FDA) approved the drug Gleevec, formerly known as…
Diagnostics | FDA | Medicine | Pharmaceutical | Therapeutics
The Best Pharmaceuticals for Children Act improved safety and efficacy of patented and off-patent medicines for children
In 2002, the U.S. Congress passed the Best Pharmaceuticals for Children Act that improved safety and efficacy of…