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Topic: United States Food and Drug Administration

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	ScienceDaily: Food and Drug Administration
		The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States.
		Food and Drug Administration -- The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics,...
		Food groups -- The food groups are part of a method of classification for the various foods that humans consume in their everyday lives, based on the nutritional properties of these types of foods and their...
	www.sciencedaily.com /encyclopedia/food_and_drug_administration (1490 words)

	EH.Net Encyclopedia: History of Food and Drug Regulation in the United States
		Food and drug regulation as we know it today in the United States had its roots in the late nineteenth century when state and local governments began to enact food and drug regulations in earnest.
		Other dimensions (for instance, the ingredients contained in certain foods, the caloric content of foods, whether or not an item is “organic,” or the therapeutic merits of medicines) are better characterized as credence goods since it may not be obvious to even a sophisticated consumer whether or not he has been cheated.
		The Bureau of Chemistry was renamed the Food, Drug, and Insecticide Administration in 1927.
	eh.net /encyclopedia/?article=Law.Food.and.Drug.Regulation (5423 words)

	Food and Drug Administration - Wikipedia, the free encyclopedia
		The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States.
		One of the key issues of drug safety dealt with by the FDA, and responsible for much recent controversy, is related to the concept of patents.
		Drug companies are allowed to spend less time describing risks and side effects on TV commercials.
	en.wikipedia.org /wiki/FDA (2455 words)

	NationMaster - Encyclopedia: Multivitamin
		Because of their categorization as a dietary supplement by the FDA, most multivitamins sold in the U.S. are not required to undergo the same rigorous testing procedures typical of pharmaceutical drugs.
		The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States.
		Multivitamins are used to treat vitamin shortages in the body that may occur because of illness, pregnancy, poor nutrition, decreased absorption of foods through the stomach, and many other circumstances.
	www.nationmaster.com /encyclopedia/Multivitamin (891 words)

	HB2180 - 462R - House Bill Summary
		The United States Food and Drug Administration is currently conducting 3,799 clinical trials in the United States, 402 of which are in Arizona.
		Authorizes payments from a medical researcher to a physician in connection with identifying and monitoring patients for a clinical trial regulated by the United States Food and Drug Administration.
		Clarifies that accepting payments from a medical researcher in connection with identifying and monitoring patients for a clinical trial is not an act of “unprofessional conduct” as defined in the physician statutes.
	www.azleg.state.az.us /legtext/46leg/2r/summary/h.hb2180_03-30-04_astransmittedtogovernor.doc.htm (302 words)

	The LitiGator
		However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval.
		(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat.
		This provision evinces a legislative policy that a drug which has been subjected to the approval process of the FDA and has passed its scrutiny may not be determined by trial courts to be unreasonably unsafe, unless one of the two specified exceptions applies.
	radio.weblogs.com /0110436/2003/04/20.html (1116 words)

	CITIZEN PETITION BEFORE THE UNITED STATES FOOD AND DRUG ADMINISTRATION
		Pursuant to the Administrative Procedure Act and Food, Drug and Cosmetic Act, 21 U.S.C. 360j(e), granting the FDA the power to restrict the use of medical devices and to require labeling, and 21 USC sec.
		The Federal Food, Drug and Cosmetics Act, as modified by the Medical Device Amendment of 1976, requires notification to the FDA by manufacturers prior to placing a new medical device on the market.
		The phrase "adequate directions for use" pertains to over-the-counter drugs and devices It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.
	www.noharm.org /details.cfm?type=document&ID=300 (4302 words)

	Journal of Medical Internet Research - Cyberpharmacies and the role of the US Food And Drug Administration (Site not responding. Last check: 2007-10-08)
		The Food and Drug Administration (FDA or the Agency) is concerned about the public health implications of Internet drug sales, and we are responding to these concerns as part of our overall goal of developing and implementing risk-based strategies to protect public health and safety.
		The prescribing requirement is based on the principle that certain drugs have risks of such significance associated with them that they should be administered only under the supervision and recommendation of a "learned intermediary" - that is, a licensed practitioner with the education and training necessary to oversee the administration of potentially harmful drug products.
		Similarly, the States have enacted laws regulating the practice of pharmacy and the practice of medicine in order to protect patients from harm resulting from the use of unsafe drugs, counterfeit drugs, and the improper practice of medicine and pharmacy.
	www.jmir.org /2001/1/e3 (4493 words)

	Buyouts Lift Biotechs - Forbes.com (Site not responding. Last check: 2007-10-08)
		Myogen's lead drug candidate is ambrisentan, a new type of treatment for pulmonary arterial hypertension, a blood pressure disorder of the lungs.
		The United States Food and Drug Administration cleared the drug to treat irritability in autistic children.
		The drug will be used as a medication for a rare cancer known as cutaneous T-cell lymphoma and will have a wholesale price of $240 per daily treatment.
	www.forbes.com /markets/2006/10/06/gilead-dynavax-merck-markets-cx_pk_1006roundupbiotech.html (508 words)

	United States Food and Drug Administration (Site not responding. Last check: 2007-10-08)
		Foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.
		The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
		FDA regulations require that foods be kept safe throughout the distribution system including transit.
	www.wnpa.com /foodsafetyforum/gov_agencies/usfda.html (331 words)

	NRDC Pro: Petition before the United States Food and Drug Administration (Site not responding. Last check: 2007-10-08)
		The Natural Resources Defense Council (NRDC) hereby petitions the Commissioner of the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., and the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), to amend the FDA's rules respecting bottled water.
		Reporting should be required within 24 hours to state and FDA officials if there us an acute violation, or within 7 days for other violations of standards.
		States or certified third parties using EPA or FDA-approved curricula for drinking water or bottled water operators could carry out such certification and training.
	fluoride.oralhealth.org /papers/1999/nrdcbwpet.html (3419 words)

	Declaration of Daniel A. Spyker, Ph.D., M.D. - 6/13/93
		Because marijuana is not a drug approved by the FDA, distribution of marijuana outside the IND process is in violation of the Act.
		Before the National Institute on Drug Abuse can supply marijuana to the sponsoring physician for a single-patient IND, because the drug is regulated under the Controlled Substances Act, the physician must apply to and receive approval from the Drug Enforcement Administration, the Department of Justice, to receive and dispense the marijuana.
		When the Drug Enforcement Administration issues a registration for the physician to receive the marijuana, it provides the order form which must be presented to the National Institute on Drug Abuse for shipment of the marijuana.
	www.druglibrary.org /olsen/MEDICAL/spyker.html (1081 words)

	Pioglitazone Glimepiride New Drug Application
		LINCOLNSHIRE, Ill., June 30, 2005 -- Takeda Pharmaceuticals North America today announced that the company has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes.
		Glimepiride should not be taken by patients with hypersensitivity to the drug or with diabetic ketoacidosis.
		Administration of an oral hypoglycemic drug similar to glimepiride has been associated with increased cardiovascular mortality as compared to treatment with diet and exercise alone or diet plus insulin.
	www.drugs.com /nda/pioglitazone-glimepiride_050630.html (632 words)

	Send to a Friend - IPS Inter Press Service
		Some observers are now suggesting that the United States should take a cue from the European model, where new drugs are reevaluated five years after they are marketed and where pharmaceutical companies must follow through on promised safety studies.
		Under the current FDA system, drug companies have finished less than one-half of the post-approval studies they pledged to conduct, and many have not even been started, according to the 'Journal of the American Medical Association'.
		For example, the Bush administration's President's Emergency Plan for AIDS Relief, which funds treatments in developing countries, stipulates that if cheaper generic drugs are to be used, they must be approved for ”bio-equivalency” to their brand-name counterpart by the FDA.
	www.ipsnews.net /sendnews.asp?idnews=26509 (841 words)

	FreeLists / nethappenings / RESOUR> [NetGold] MEDICAL: NEWS : PRODUCTS: ALERTS: United States. Food and Drug ...
		FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.
		FDA emphasizes that, for the 7 drugs evaluated in pediatric major depressive disorder (MDD), data reviewed by FDA were adequate to establish effectiveness in MDD for only one of these drugs, Prozac (fluoxetine).
		Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
	www.freelists.org /archives/nethappenings/10-2003/msg00153.html (857 words)

	PRESS RELEASE Aradigm Files Request for Orphan Drug Designation for Inhaled Liposomal Ciprofloxacin for Cystic Fibrosis (Site not responding. Last check: 2007-10-08)
		Orphan drug status may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 persons in the United States.
		CF is a genetic disease affecting roughly 30,000 children and adults in the United States and roughly 60,000 worldwide.
		CF is the most common fatal genetic disease in the United States.
	www.marketwire.com /mw/release_html_b1?release_id=105284 (461 words)

	Food and Drug Administration (Harpers.org)
		The United States Food and Drug Administration issued a “draft guidance” concerning a proposal to fllist foreign companies that import defective condoms; the report said that “continuous monitoring of these devices is needed.” Democratic Representative Loretta Sanchez cancelled a Playboy Mansion fundraiser after Al Gore objected to it.
		The Food and Drug Administration proposed banning two antibiotics known as fluoroquinolones, which are given to whole flocks of chickens in their water, because they cause camplyobacter bacteria to develop a resistance to antibiotics.
		The Food and Drug Administration was trying to decide whether it's ethical to give children amphetamines as part of a study.
	www.harpers.org /FDA.html (1198 words)

	Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
		Title II Food Aid of the Agricultural Trade Development and Assistance Act of 1954 (Public Law 480) is requested by the Department of Agriculture and administered by USAID.
		Title II resources have been critical to saving lives by preventing and mitigating famines and providing urgent relief to victims of natural disasters and complex emergencies where natural disasters are compounded by ongoing civil strife.
		Through this program, the United States also provides development-oriented resources to private voluntary organizations and the world Food Program to help improve the food security of needy people through the direct distribution of agricultural commodities or the use of local currencies generated by the sale of these commodities in the recipient country.
	www.state.gov /s/d/rm/rls/iab/2007/html/60202.htm (363 words)

	Planet Ark : U.S. says EU needs own food and drug administration
		The EU has suspended authorisation of new genetically modified crop strains from the United States in response to an outburst of public concern over food safety in the wake of the mad cow disease in Britain and dioxin poisoning in Belgium.
		Aaron is due to meet some of the newly appointed EU Commissioners in Brussels on Friday in a bid to ease trade tensions between the United States and the 15-nation bloc.
		Apart from modified foods, the two sides argue on issues as diverse as EU farming subsidies, data protection in e-commerce and ways of reducing jet noise levels.
	www.planetark.org /dailynewsstory.cfm/newsid/3708/newsDate/17-Sep-1999/story.htm (745 words)

	eMedicine Online Medical Textbooks by Specialty: Free Journal Articles and Texts for Physicians and Health Professionals (Site not responding. Last check: 2007-10-08)
		The Food and Drug Administration (FDA) advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
		Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia.
		The United States Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol.
	www.emedicine.com /recalls-alerts.asp?year=2005 (14725 words)

	FindArticles search for "United States. Food and Drug ..."
		The FDA has stated that it has no objections to the Sensus America LLC claim that its inulin is GRAS (Submission Notice No. GRN 00018).
		The Food and Drug Administration issued a final guidance providing recommendations for assessment of donor suitability and product safety for donors potentially exposed to Bacillus anthracis.
		Probably not--but drug recalls have sparked debate Debate in the United States about the optimal amount of time required by the Food and Drug Administration...
	www.findarticles.com /p/search?tb=art&qt=United+States.+Food+and+Drug+... (867 words)

	Defendants Sentenced for Selling Prescription Drugs on Norfold Men's Clinic Web Site (June 18, 2002) (Site not responding. Last check: 2007-10-08)
		Leura Garrett Canary, United States Attorney for the Middle District of Alabama, announced today that Anton F. Pusztai, an Australian citizen, and Anita Yates, of Clanton, Alabama, were sentenced on charges related to illegally offering prescription drugs over the Internet to consumers through a website called Norfolk Men’s Clinic in Clanton, Alabama.
		United States District Judge Anthony Alaimo, visiting from the Southern District of Georgia, presided over the trial of this case.
		This case was prosecuted by Assistant United States Attorney Tommie Brown Hardwick, and Trial Attorney Linda I. Marks, Office of Consumer Litigation, Washington, D.C., and was investigated by Special Agent Robert J. West, Office of Criminal Investigations, United States Food and Drug Administration, and Lieutenant J. Shane Fulmer, Chilton County Sheriff’s Office.
	www.usdoj.gov /criminal/cybercrime/pusztaiSent.htm (576 words)

	Administration Drug Food (Site not responding. Last check: 2007-10-08)
		This document explores the Food and Drug Administration's actions since that time, noting inconsistancies and biases concerning the FDA's action against the use of colloidal silver.
		Everything that you could ever want to know about food and drug administration, there is more information here than you ever dreamed of Sponsored Links food and drug administration Welcome to...
		Food and Drug Administration Plan Focuses on Patient Safety and Reducing Med...
	www.drugpolicydigest.com /administrationdrugfood (919 words)

	Biocompare News - The United States Food And Drug Administration Grants Orphan Drug Status To Lorus Therapeutics' ...
		In partnership with the United States National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) under a clinical trials agreement, Lorus and CTEP are expanding the Phase II clinical development of GTI-2040 to include additional clinical trials for the treatment of other cancer types.
		There is a clear need for drugs with lower toxicities to treat patients with this difficult disease.
		Lorus' goal is to capitalize on its research, pre-clinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination, to successfully manage cancer.
	news.biocompare.com /newsstory.asp?id=9720 (558 words)

	Weakened Immunity: How the Food and Drug Administration Caused Recent Vaccine-Supply Problems: The Independent Review: ...
		All fifty-two state and local programs that responded to a GAO survey reported that they “experienced shortages of two or more vaccines.” Approximately two-thirds reported “shortages with five or more” of the eight vaccines.
		The drug was effective in relieving morning sickness, yet tragically it caused deformities in some ten thousand children.
		But if the drug is shown to be responsible for killing a specific individual, then that loss becomes much more identifiable than all the survivors.
	www.independent.org /publications/tir/article.asp?issueID=38&articleID=213 (8540 words)

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