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*  Australian Drug Evaluation Committee
... of drugs referred to ADEC for evaluation medical and scientific evaluations of applications for registration of new drugs An ... The Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian ... The two main subcommittees of ADEC which were responsible for specific aspects of drug regulation in Australia: the Adverse ... Food and Drug Administration (FDA, USA) European Medicines Agency (EMEA, EU) Health Products and Food Branch ADEC website. ...
*  Center for Drug Evaluation and Research
In its original form, CDER was composed of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug ... The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug ... The Division of Antiviral Products was added in 1989 under Drug Evaluation II due to the large amount of drugs proposed for ... and for the evaluation of new drug applications The Office of New Drugs is divided into several departments based on the ...
*  Approved Drug Products with Therapeutic Equivalence Evaluations
... for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public ... The Drug Price and Competition Act (Hatch-Waxman Act) requires FDA to publish Approved Drug Products with Therapeutic ... In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must ... The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy ...
*  Fluvoxamine
An Updated Review of its Use in the Management of Adults with Anxiety Disorders". Adis Drug Evaluation. 60 (4): 925-954. doi: ... ISBN 978-0-85711-084-8. "Summary of Full Prescribing Information: Fluvoxamine". Drug Registry of Russia (RLS) Drug Compendium ( ... The drug works long-term, and retains its therapeutic efficacy for at least a year. It has also been found to possess some ... It was the first SSRI, a non-TCA drug, approved by the U.S. FDA specifically for the treatment of OCD. At the end of 1995, more ...
*  Pregnancy category
Medicines in Pregnancy Working Party (14 February 2007). "Prescribing medicines in pregnancy". Australian Drug Evaluation ... February 1996). "Drugs during pregnancy: an issue of risk classification and information to prescribers". Drug Saf. 14 (2): 69- ... is now available in the individual drug monographs. American law requires that certain drugs and biological products must be ... Labeling Requirements for Prescription Drugs and/or Insulin. Food and Drug Administration. April 1, 1997. Archived from the ...
*  Side effects of penicillin
Center for Drug Evaluation. Retrieved 19 May 2017. Potter, p. 897. Harrison, E. M.; Weinert, L. A.; Holden, M. T. G.; Welch, J ... Common adverse drug reactions (≥ 1% of people) associated with use of the penicillins include diarrhoea, hypersensitivity, ... Model of Structure of Penicillin, by Dorothy Hodgkin et al., Museum of the History of Science, Oxford Food and Drug ... Cooper, Chuck (9 January 2015). "Bioterrorism and Drug Preparedness - Safety of Long Term Therapy with Penicillin and ...
*  Surrogate endpoint
Clinical Measurement in Drug Evaluation. Edited by Nimmo WS, Tucker GT. New York: Wiley; 1995. Pedersen TR, Olsson AG, ... The company counters that it had been tested on larger groups of patients than any other drug in the class, and that its ... A clinical trial may show that a particular drug (for example, simvastatin (Zocor)) is effective in reducing cholesterol, ... 1999). "Surrogate end points, health outcomes, and the drug approval process for the treatment of risk factors for ...
*  CYP2B6
Center for Drug Evaluation and Research. "Drug Interactions & Labeling - Drug Development and Drug Interactions: Table of ... Walsky RL, Astuccio AV, Obach RS (2006). "Evaluation of 227 drugs for in vitro inhibition of cytochrome P450 2B6". J Clin ... 2010). "The convergence of therapeutic drug monitoring and pharmacogenetic testing to optimize efavirenz therapy". Ther Drug ... "Drug Interactions: Cytochrome P450 Drug Interaction Table". Indiana University School of Medicine. Retrieved on December 25, ...
*  Monitoring in clinical trials
According to the U.S. Food and Drug Administration's Center of Drug Evaluation and Research, the top five deficiency categories ... "Center for Drug Evaluation and Research". ASPE. 2015-11-23. Retrieved 2017-11-30. "Guidance for Industry: Oversight of Clinical ... Clinical trials Data monitoring committee Drug development European Medicines Agency Safety monitoring U.S. Food and Drug ... Drug Administration (FDA), and the institution funding the research. The FDA itself maintains an Adverse Event Reporting System ...
*  Dose (biochemistry)
Research, Center for Drug Evaluation and. "How Drugs are Developed and Approved - OTC (Nonprescription) Drugs". www.fda.gov. ... By combining these drugs with a system that detects the concentration of drug particles in the blood, proper dosing could be ... Prescription drug dosage is based typically on body weight. Drugs come with a recommended dose in milligrams or micrograms per ... Whether a drug is ingested orally, injected into a muscle or vein, absorbed through a mucus membrane, or any of the other types ...
*  Declaration of Helsinki
Center for Drug Evaluation and Research. Guidance for industry: acceptance of foreign clinical studies. March, 2001 Temple R. ... The Nation May 19, 2008 "Trials on trial: The Food and Drug Administration should rethink its rejection of the Declaration of ... This led to the US Food and Drug Administration (FDA) ignoring this and all subsequent revisions. Following the fourth revision ... DHHS FDA 21 CFR part 312 Human Subject Protection: Foreign clinical studies not conducted under an investigational new drug ...
*  Moprolol
Research, Center for Drug Evaluation and. "Warning Letters and Notice of Violation Letters to Pharmaceutical Companies - ... In 1972 SIMS first submitted a Drug Master file to the US FDA and has continued to do so over the years. In addition to ... Before being pulled from the market moprolol was a prescription drug, meaning it must be prescribed from a doctor, and could ...
*  Manchester (The West Wing)
"NDA 20-687". Center for Drug Evaluation and Research. 2000-09-28. Archived from the original on March 9, 2008. Retrieved 2008- ... Such a drug, called Mifepristone, was in fact approved in the United States in September 2000; one of the last months of the ... "Sorkin's drug subplot ending". The Dallas Morning News. Archived from the original on 2007-03-19. Retrieved 2008-06-30. " ...
*  Palonosetron
ISBN 978-0-911910-00-1. "Chemistry Revire - Aloxi (Palonosetron HCl) Capsules, 0.5 mg" (PDF). Center for Drug Evaluation and ... These drugs act by blocking serotonin from binding to the 5-HT3 receptor. Orally taken palonosetron is absorbed well from the ... ISBN 978-3-7741-9846-3. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (14 ed.). Merck & Co. 2006. p. ... There are case reports about serotonin syndrome when the drug is combined with serotonergic substances such as selective ...
*  Cyclin-dependent kinase
Research, Center for Drug Evaluation and. "Approved Drugs - FDA approves abemaciclib for HR-positive, HER2-negative breast ... Complications of developing a CDK drug include the fact that many CDKs are not involved in the cell cycle, but other processes ... Although it was originally developed as a potential anti-cancer drug, seliciclib has also proven to induce apoptosis in ... This means that novel drugs for treatment of chronic inflammation diseases such as arthritis and cystic fibrosis could be ...
*  Sanguinarine
Research, Center for Drug Evaluation and. "Enforcement Activities by FDA - 187 Fake Cancer". www.fda.gov. Retrieved 2017-05-07 ... During the 1920s and 1930s, sanguinarine was the chief component of "Pinkard's Sanguinaria Compound," a drug sold by Dr. John ... Das, M; Khanna, S. K. (1997). "Clinicoepidemiological, Toxicological, and Safety Evaluation Studies on Argemone Oil". Critical ... Food and Drug Administration warns that products containing bloodroot, or other sanguinarine-based plants, have no proven anti- ...
*  Lurasidone
PMC 3346058 . "Lurasidone pharmacology review" (PDF). Center for Drug Evaluation and Research. 30 December 2009. http://www.mmm ... "Lurasidone drug-drug interaction studies: a comprehensive review". Drug Metabolism and Drug Interactions. 29 (3): 191-202. doi: ... The FDA approved the drug in 2010. In India, this drug is available under the brand name of Lurafic,Luramax,Lurata.[citation ... "Latuda: Prescribing Information". Psychotherapeutic Drugs. Retrieved 2010-12-17. "Latuda". Drugs.com. Retrieved 2010-12-17. ...
*  Anti-diabetic medication
Research, Center for Drug Evaluation and. "Drug Safety and Availability - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors". ... Among common diabetic drugs, metformin is the only widely used oral drug that does not cause weight gain. Typical reduction in ... The "second-generation" drugs are now more commonly used. They are more effective than first-generation drugs and have fewer ... "The Oral Diabetes Drugs: Treating Type 2 Diabetes" (PDF). Best Buy Drugs. Consumer Reports: 20. Retrieved September 18, 2012 ...
*  Cancer immunotherapy
Research, Center for Drug Evaluation and. "Approved Drugs - Durvalumab (Imfinzi)". www.fda.gov. Retrieved 2017-05-06. Byrd JC, ... "Opdivo Drug Approval History". James JS, Dubs G (December 1997). "FDA approves new kind of lymphoma treatment. Food and Drug ... Anti-PD-1 drugs contain not only an Fab region that binds PD-1 but also an Fc region. Experimental work indicates that the Fc ... Many cancer immunotherapy drugs, including PD-1 and PD-L1 inhibitors, are antibodies. For example, immune checkpoint blockers ...
*  Diffuse large B-cell lymphoma
Research, Center for Drug Evaluation and. "Approved Drugs-FDA approves axicabtagene ciloleucel for large B-cell lymphoma". www. ... These drugs are administered intravenously, and the regimen is most effective when it is administered multiple times over a ... "A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's ... A second regimen under evaluation is R-EPOCH (rituximab with etoposide-prednisone-vincristine-doxorubicin-cyclophosphamide), ...
*  Biologics Price Competition and Innovation Act of 2009
Drug, and Cosmetic Act (FD&C Act). Research, Center for Drug Evaluation and. "Information on Biosimilars". www.fda.gov. http:// ... The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the " ... "Hatch-Waxman Act"), which established abbreviated pathways for the approval of drug products under the Federal Food, ... www.fda.gov/downloads/Drugs/.../Guidances/UCM273001.pdf. ...
*  Creatinine
"Carboplatin dosing". Center for Drug Evaluation and Research. Archived from the original on 2011-11-19. Harita N, Hayashi T, ... The dose, unless further modified, could now be higher than desired, potentially causing increased drug-related toxicity. To ... Creatinine concentration is also checked during standard urine drug tests. Normal creatinine levels indicate the test sample is ... a chemotherapy drug. A 2009 Japanese study found a lower serum creatinine level to be associated with an increased risk for the ...
*  Quinolone antibiotic
Research, Center for Drug Evaluation and. "Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs ... Farinas, Evelyn R; Public Health Service Food and Drug Administration Center for Drug Evaluation and Research (1 March 2005). " ... On 5 November 2015, the U.S. FDA held a joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and ... In 2017 the FDA included the following important warning: "The U.S. Food and Drug Administration (FDA) has required the drug ...
*  Personal genomics
Research, Center for Drug Evaluation and. "Genomics - Table of Pharmacogenomic Biomarkers in Drug Labeling". www.fda.gov. ... These treatment plans will be able to prevent or at least minimize the adverse drug reactions which are a, "significant cause ... Pharmacogenomics is the study of how a person's genome affects their response to drugs. This field is relatively new but ... This field allows researchers to better understand how genetic differences will influence the body's response to a drug and ...
*  Gene therapy
U.S. Food and Drug Administration. 30 August 2017. Research, Center for Drug Evaluation and. "Approved Drugs - FDA approves ... Food and Drug Administration. Center for Biologics Evaluation and Research. Guidance for Industry: Guidance for Human Somatic ... Gene therapy is the therapeutic delivery of nucleic acid into a patient's cells as a drug to treat disease. The first attempt ... As of 2016, only one person had been treated with drug. In December 2012, it was reported that 10 of 13 patients with multiple ...