
	Where results make sense

Topic: Therapeutics Goods Administration

	Audit Report - Drug Evaluation by the Therapeutic Goods Administration (Site not responding. Last check: 2007-11-04)
		The Therapeutic Goods Administration (TGA) is a sub-program of the Department of Health and Family Services, with an objective of ensuring that the safety, quality and efficacy of therapeutic goods available in Australia is at a standard equal to that of comparable countries.
		TGA has already completed an activity based costing of its manufacturer auditing and licensing functions, and studies in other areas (including the DSEB) are either underway or planned for completion before the end of the year.
		This means that TGA must streamline its operation to the maximum while maintaining a high level of effectiveness to ensure the quality of our work and the quality, safety, efficacy and availability of therapeutic goods in Australia.
	www.anao.gov.au /WebSite.nsf/Publications/4A256AE90015F69B4A25690B001FD256 (10950 words)

	Medicines Evaluation Committee (MEC)
		The MEC became a Statutory Committee as a result of amendments to the Therapeutic Goods Regulations commencing 31 March 2000.
		Therapeutic goods being considered for inclusion in Part 3 of Schedule 10 to the Therapeutic Goods Regulations
		Therapeutic goods specified by the Minister or the Secretary
	pandora.nla.gov.au /pan/10754/20030610/www.health.gov.au/tga/docs/html/mecinfo.htm (530 words)

	Media Release: TGA Recalls Potentially Defective Replacement Hips
		The Therapeutics Goods Administration (TGA) today initiated a recall of zirconia ceramic femoral head hip replacement components manufactured by Saint-Gobain Ceramiques Avancees Desmarquest in France following reports of serious failures with the product.
		Recommended orthopaedic surgeons inform all patients implanted with a Saint Gobain Céramiques Avancées Desmarquest zirconia femoral head prosthesis that they should seek urgent medical attention should they be concerned that there is a sudden change in their replaced hip.
		The TGA urges recipients of hip replacement devices not to be overly alarmed but to contact their GP or orthopaedic surgeon.
	pandora.nla.gov.au /pan/10941/20021108/www.health.gov.au/tga/docs/html/media_rel.htm (452 words)

	eMJA: Adverse event reporting in clinical trials: room for improvement
		Sponsors are required to report to the Therapeutics Goods Administration (TGA) all individual adverse events (defined as any untoward medical occurrences in patients or clinical investigation subjects, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) recorded in Australia, but not events that occur overseas.
		In the administrative situation created by the current process, serious safety concerns may be missed in an ever-growing paper trail.
		Good clinical practice requires close scrutiny to ensure that it is not only ethical, but also practical.
	www.mja.com.au /public/issues/179_08_201003/lia10260_fm-1.html (1855 words)

	Anadis will not repeat drug tests - News - www.theage.com.au
		On Monday, The Age reported that Travelan had been called in by the Therapeutics Goods Administration for analysis because it contained Citrus x Paradisi, an ingredient known to contain a toxic chemical, benzethonium chloride, which is commonly used as an industrial cleaner and disinfectant.
		Before the TGA was able to analyse Travelan, Anadis opted to remove the ingredient entirely and is in the final stages of manufacturing and packaging the tablets for sale.
		Following inquiries by the TGA, Mr Graham said Anadis had elected to remove the Citrus x Paradisi because it was a "preservative" and not an active ingredient in Travelan.
	www.theage.com.au /articles/2004/08/17/1092508469536.html (336 words)

	Encyclopedia: Bioequivalence
		Pharmacokinetics is a branch of pharmacology dedicated to the study of the time course of substances and their relationship with an organism or system.
		Pharmaceutical equivalence implies the same amount of the same active substance(s), in the same dosage form, for the same route of administration and meeting the same or comparable standards."
		Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug.
	www.nationmaster.com /encyclopedia/Bioequivalence (294 words)

	Natural Alternatives International, Inc. (Site not responding. Last check: 2007-11-04)
		In October, 2002, the company was awarded a Good Manufacturing Practices (GMP) registration by the National Safety Foundation (NSF) under its new Dietary Supplements Certification Program.
		NAI also maintains GMP certification from the prestigious Therapeutics Goods Administration (TGA), an Australian government agency that regulates therapeutic goods for safety and efficacy.
		TGA certification is recognized internationally by more than 30 countries.
	ir.thomsonfn.com /InvestorRelations/IRfiles/2846/2002/operational_excellence.htm (296 words)

	Info and facts on 'Bioequivalence' (Site not responding. Last check: 2007-11-04)
		Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics.
		In Australia, the Therapeutics Goods Administration (TGA) considers preparations to be bioequivalent if the 90% confidence interval (additional info and facts about confidence interval) s (90% CI) of the transformed natural log (additional info and facts about natural log) ratios, between the two preparations, of C
		is only considered important if the onset time is therapeutically relevant (e.g.
	www.absoluteastronomy.com /encyclopedia/b/bi/bioequivalence.htm (203 words)

	Tuta Healthcare - Company Information
		The first stage was to upgrade and relocate the administration offices.
		The second stage involved the relocation, to the same building as the administration area, of all extrusion, blowmoulding and injection moulding bringing it into our existing clean room facility.
		TUTA HEALTHCARE Pty Limited is licensed by the Therapeutics Goods Administration in Canberra to manufacture non-implantable medical devices and maintains a Quality Management System in compliance with European Standard EN 46001-1996.
	www.tuta.com.au /page/company_information.html (399 words)

	Therapeutic Goods Administration A-Z guide
		TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use
		TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells
		Therapeutic Goods Administration (TGA) policy for the export of medicines from Australia
	www.tga.gov.au /docs/html/azguide.htm (1413 words)

	ShareTrader - PTD In Demand (1) (Site not responding. Last check: 2007-11-04)
		Gerry has posted alot of excellent info on this one, stuff I could not have the time to get myself so its good to follow the stocks you guys are looking into.
		Peptech's human research and development is currently focussed on the development of a product that will provide 6 months suppression of testosterone production in patients with prostate cancer.
		Therapeutics Goods Administration (TGA) approval has been obtained for Peptech's North Ryde manufacturing facility allowing manufacture of implants for human clinical trials.
	www.sharetrader.co.nz /topic.asp?ARCHIVE=true&TOPIC_ID=14581&whichpage=6 (1780 words)

	The Pharmaceutical Drug Racket - Part one
		According to the Food and Drug Administration (FDA), 1.5 million Americans were hospitalized in 1978 as a consequence of taking drugs and some 30 per cent of all hospitalized people are further damaged by their treatments.
		As the academic physician does not depend upon the good will of the patient for his or her livelihood, the patient's well-being becomes of minor consideration to him or her.
		In Australia, a repeal of Schedule 1, Exemptions of the Therapeutic Goods Act, scheduled for January 1994, would minimize access to natural therapy remedies by natural therapists and would threaten the existence of the natural therapy profession and manufacturers of natural therapy remedies.
	www.detoxifynow.com /drug_racket.html (7515 words)

	Abridged Information About the New TGA Advertising Code
		The legislation referred to is “Therapeutic Goods Regulations Advertising Code of 1989 (Amendment) Statutory Rules Nos.
		Amendment No 400 requires all promotional materiel of natural health products to be submitted to the Secretary of the Therapeutics Goods Administration (TGA) accompanied with a reported fee of $180, for approval prior to publication in any mainstream media, and prohibits any claim of therapeutic benefits.
		We started looking into the TGA issue and find that is it is only the tip of the iceberg as to what is happening in this country.
	www.iahf.com /asia/abridged.html (1394 words)

	Expert committee reports on HRT (Site not responding. Last check: 2007-11-04)
		An Australian expert committee, convened by the Therapeutics Goods Administration yesterday to evaluate a just released US study that cast doubts on the safety of combination hormone replacement therapy (HRT), has released its report.
		An Australian expert committee, convened by the Therapeutics Goods Administration yesterday to evaluate a just released US study that cast doubts on the safety of combination hormone replacement therapy (HRT), has recommended combination HRT to manage symptoms of menopause is still an appropriate treatment option.
		Releasing the Expert Committee's report today, Ms Trish Worth, Parliamentary Secretary to the Commonwealth Minister for Health and Ageing, said the committee clearly had some concerns about HRT and it strongly recommended that women discuss their particular circumstances with their doctor as individual factors may affect the risks and benefits of treatment for them.
	www.health.gov.au /mediarel/yr2002/tw/tw02025.htm (370 words)

	Articles - Bioequivalence (Site not responding. Last check: 2007-11-04)
		In determining bioequivalence, for example, between two products such as a commercially-available Brand product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study to volunteer subjects, generally healthy individuals but occasionally in patients.
		In Australia, the Therapeutics Goods Administration (TGA) considers preparations to be bioequivalent if the 90% confidence intervals (90% CI) of the transformed natural log ratios, between the two preparations, of C
		Although there are a few exceptions, generally a bioequivalent comparison of Test to Reference formulations also requires administration after an appropriate meal at a specified time before taking the drug, a so-called "fed" or "food-effect" study.
	www.mafox.com /articles/Bioequivalence (391 words)

	Melbourne varicose vein, spider vein and venous ulcers treatment specialists Centres in Melbourne Victoria Australia.
		The Therapeutics and Goods Administration (TGA) have approved the use of sclerosant solution for clinical use in Australia several years ago.
		Applications have been made to the TGA for the use of foam but this approval process takes time.
		Until then, the use of foam does not have formal TGA approval.
	www.veinsolutions.com.au /treatments.htm (810 words)

	ANSTO Annual Report 1999 2000. Core Business. Sustainability and international competitiveness of industry (Site not responding. Last check: 2007-11-04)
		ANSTO’s new dry-bed technetium generator, Gentech(R), was approved by the Therapeutics Goods Administration and commercially released in February.
		ANSTO maintained its Therapeutic Goods Administration licence as a single stage manufacturer for radiation sterilisation of health care products and medical devices.
		Potential applications include therapeutic use, and the use of tracer doses of the labelled drugs to determine biodistribution and tumour targeting, thereby minimising toxicity and maximising therapeutic effectiveness for individual patients.
	www.ansto.gov.au /info/reports/ar9900/ind.html (4827 words)

	BB Archives August - September 02 (Site not responding. Last check: 2007-11-04)
		Unlike some aloe juices, this is not suitable to drink as the variety of aloe used is perfect for topical application and it has been incorporated into a range of skin and hair care products.
		The company has had its products approved by the Therapeutics Goods Administration and is in the process of being certified organic for the way in which the aloe vera is grown in the Byron Bay hinterland farm of Wild Nature.
		Aloe vera has a range of different active ingredients in its pulp that have been recognised as anti-inflammatories, a mild analgesic and a humectant to promote the retention of water in the skin.
	beautybiz.com.au /bb_htm/archives/ibb_arcBB_10as02.htm (2564 words)

	The Oil Garden - About Us
		The Oil Garden Aromatherapy range of pure Essential Oils, Therapeutic Creams and Skin, Hair and Body Care is the most comprehensive in Australia.
		The Oil Garden Essential Oils and Therapeutic Creams are TGA licensed to guarantee their purity and efficacy.
		Purity owns and operates a TGA (Therapeutics Goods Administration) licensed facility where all products are produced to the highest quality standards.
	www.purityaustralia.com /About_Us.htm (387 words)

	PART B (Site not responding. Last check: 2007-11-04)
		Australia has a tradition of excellence in health and medical research, which is critical to the good quality of health that Australians enjoy.
		In 1999-2000, there will be a focus on reducing the adverse health impact of illicit and licit drug use, communicable diseases and vaccine preventable conditions in the community.
		The Departmental Expenses reported in each Outcome for 1999-2000 reflect the predicted cost of the outputs to be produced by the relevant areas contributing to the Outcome.
	www.dhac.gov.au /pubs/budget99/pbs/partb.htm (2532 words)

	The Pharmaceutical Benefits Scheme - an Overview
		Therapeutic Group Premium items do not count towards safety nets.
		Australian Drug Evaluation Committee (ADEC) a committee of the Therapeutics Goods Administration.
		If ADEC recommends that the drug should be available for sale in Australia, a sponsor usually the drug company - but sponsors can also include medical bodies, health professionals, private individuals and their representatives - applies to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the PBS.
	www.aph.gov.au /library/intguide/SP/pbs.htm (2847 words)

	Drug Evaluation
		The time taken by the TGA to evaluate an application for registration of a prescription medicine depends on a number of factors.
		Australia's medicines watchdog, the Therapeutic Goods Administration (TGA) has introduced tough new measures on the prescribing of anti-arthritis drugs known as Cox-2 Inhibitors following the findings of a review into the safety of this family of medicines.
		The aim of these guidelines is to enhance transparency in the operations of the Export Medicines Unit of the TGA and ensure consistency in the administrative processes which support the Therapeutic Goods legislation.
	www.healthinsite.com /topics/Drug_Evaluation (619 words)

	dir185/nrl-pub.nsf (Site not responding. Last check: 2007-11-04)
		At the end of the workshop participants were asked to complete a questionnaire designed to assess the overall impact of the workshop in terms of relevance, educational value and interest.
		THE NRL's in its International Programme aims to elevate the quality of laboratory services and their management for the diagnosis and management of HIV and other blood borne pathogens throughout the South east Asian and Western Pacific regions and beyond.
		We recognize that quality laboratory testing is essential to good clinical management, effective blood screening programmes, efficacious treatment of viral disease, and for monitoring epidemics and vaccine programmes.
	www.nrl.gov.au /dir185/nrl-pub.nsf/structure/InternationalActivities-NRLA-58YVWQ (1584 words)

	WildChild Magazine (Site not responding. Last check: 2007-11-04)
		As late as 1900, medicine was therapeutically pluralistic and financially unprofitable.
		The standard of proof for therapeutic efficacy is in fact a double standard.
		Surgery was grandfathered in as standard practice early in the twentieth century without randomized, double-blind clinical trials, which only became widespread in the 1960s with the advent of chemotherapy.
	wildchildmagazine.com /display.php?id=375&lang=en (5234 words)

	AAR: Focus on Health
		You may have seen the movie "Gattaca" where Uma Thurman's character takes a strand of her potential boyfriend's hair to the genetic testing booth (conveniently located near the cloakroom of a popular night club).
		Within a few short minutes, she's advised that Mr Uma is a good catch: great genes, good fatherhood material and...
		They're either poisons that are restricted to medical, dental or veterinary prescription, or they're intended for therapeutic use, but more testing of their safety or efficacy is needed.
	www.aar.com.au /pubs/bio/fohdec00.htm (2415 words)

	Media Releases 2000
		The Australian Therapeutics Goods Administration, the European Medicines Agency and an advisory committee to the United States Food and Drug Administration have recently completed reviews of the safety of COX-2 inhibitors.
		The Food and Drug Administration are yet to make a statement on this issue.
		Prescribing data available to the TGA allows it to ascertain information on the numbers of patients using these medicines and the doses being prescribed.
	www.medsafe.govt.nz /hot/media/2005/cox2Feb05.htm (1344 words)

	The Royal Australian College of General Practitioners Content Map (Site not responding. Last check: 2007-11-04)
		Special College Fax - Advice concerning the use of SSRI antidepressants in pregnant women : The RACGP has received information from the Therapeutics Goods Administration suggesting an association between use of SSRI antidepressant medicines in early pregnancy and congenital heart abnormalities.
		College Fax 9 September 2005 : The Therapeutics Goods Administration (TGA) has this week released an alert suggesting an association between the use of SSRI antidepressant medicines in early pregnancy and congenital heart abnormalities.
		This is largely in response to the withdrawal of the arthritis drug, Vioxx, in September last year due to a significant increased risk of heart attacks and strokes.
	www.racgp.org.au /contentmap.asp (6643 words)

	UNSW: The University of New South Wales - Sydney Australia - News - Trial set to transform nursing home care
		The system is an enhanced version of the Home Telecare system successfully trialled in the past few years and to be released commercially in the next few weeks, subject to Therapeutics Goods Administration approval.
		Doctors will be able to insert any health questionnaires they want nursing staff to conduct in their daily rounds.
		And for administrators, will allow them to streamline much of the paperwork associated with managing a nursing home.
	www.unsw.edu.au /news/pad/media/2004/nov/Nursing_homecare.html (587 words)

Try your search on: Qwika (all wikis)