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Topic: Investigational New Drug

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	Conducting Outpatient Clinical Research Using Legend/Investigational New Drugs
		Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
		The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.
		Investigational drugs are to be administered in accordance with research protocol and in accordance with any other hospital or clinic policy pertaining to the administration of medications.
	www.fpd.finop.umn.edu /groups/ppd/documents/procedure/Conducting_Outpatient.cfm (1087 words)

	21 Cfr Part 312 -- Investigational New Drug Application
		An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
		If the investigation involves an exception from informed consent under § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the investigation is subject to the requirements in § 50.24 of this chapter.
		Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.
	www.research.buffalo.edu /humansubjects/21CFR312.asp (13466 words)

	Protomechanics: Chapter 5 (Site not responding. Last check: 2007-11-06)
		The drug must be FDA-approved (for a particular indication), commercially available, and subject to a definite clinical research study of another condition – for example, the early trials of cyclophosphamide for rheumatoid arthritis after the drug had been approved and put on sale for the treatment of lymphomas.
		If the drug is to be used in a way or in circumstances that make it less safe than its approved use, or if the intent of the investigation is to support labeling or advertising changes, a sponsor is needed, and an IND must be in effect for study of the new use.
		An adverse drug reaction or adverse experience is 1) an effect of a drug that is not intended or expected and that is severe enough to result in the discontinuation of the suspected medication or the administration of specific measures to overcome the adverse effect; or 2) a side effect of an experimental drug.
	www.cc.nih.gov /ccc/protomechanics/chap_5.html (2760 words)

	FDAReview.org, a project of The Independent Institute: FDA Glossary
		Drug loss is difficult to measure, although Peltzman’s (1973) results (see also the discussion in the text) suggest that it is very extensive.
		A drug was to be an OTC drug unless (1) it was habit forming, (2) had potentially harmful effects or potentially harmful effects when used by a lay person, or (3) was limited to prescription use by a New Drug Application.
		Drug sponsors henceforth had to file an Investigational New Drug Application and obtain FDA approval for all investigational studies involving humans.
	www.fdareview.org /glossary.shtml (7952 words)

	CBER - Biological Investigational New Drug Application (IND)
		An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
		Investigational New Drug Application (Form FDA 1571) - Outlines the information required in an IND. All sections on form FDA 1571 must be addressed in the submission.
		Statement of Investigator (Form FDA 1572) - When this form is completed by each investigator, the original signed copy must be given to the IND sponsor.
	www.fda.gov /cber/ind/ind.htm (463 words)

	DefenseLINK News: White House Sets Rules for Use of Investigational Drugs
		Instead, the FDA authorized DoD to use PB as an "investigational new drug" to protect troops against certain nerve agents thought to be in the Iraqi arsenal.
		Although a new literature review has indicated that PB should not be ruled out as a possible cause of Gulf War illnesses, defense leaders stand by their predecessors' decision to issue the medication.
		It takes about 10 years for a new drug to pass research tests, receive FDA licensing and be stockpiled in sufficient quantities to protect troops.
	www.defenselink.mil /news/Nov1999/n11291999_9911291.html (1183 words)

	Treatment IND (Investigational New Drug) News
		Once a drug's safety has been determined in human trials, it may be prescribed to patients that are terminally ill or suffering from diseases such as HIV/AIDS, herpes simplex encephalitis, or subarachnoid hemorrhage under the Treatment IND protocol.
		Typically Treatment IND applications are made for drugs that are in Phase III trials; however in rare cases the FDA approves a Treatment IND for a drug that has not yet progressed beyond Phase II.
		First of all, drug companies tend to eschew applying for Treatment INDs because they would rather have many of the patients who will take their drug under that protocol take part in a controlled clinical trial.
	www.fiercebiotech.com /topics/treatment_IND.asp (374 words)

	21CFR312- Investigational new drug application (Site not responding. Last check: 2007-11-06)
		An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
		An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
		If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
	www.labcompliance.com /documents/FDA/FDA-GCP/21CFR312.htm (15540 words)

	Fogarty - Research Ethics Website
		The Food and Drug Administration (FDA) is an agency within the U.S Department of Health and Human Services (DHHS) responsible for regulating human subjects research --conducted in the U.S. or funded in part with U.S. federal funds-- involving investigational drugs, biologics, and medical devices.
		Sponsors or investigator sponsors wishing to conduct clinical research with an investigational drug, biologic or device must file and Investigational New Drug application or an Investigation Device Exemption application with the FDA before commencing their research.
		The use of an FDA-approved drug is considered investigational when (a) its use is different from the FDA-approved use and (b) it poses an increased risk.
	bms.brown.edu /fogarty/fda.htm (464 words)

	U.S. CODE -- Notice of use of an investigational new drug
		Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use.
		The reasons why the investigational new drug or drug unapproved for its applied use is being administered.
		In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the
	www.avip2001.net /DOCS/Title10_Sec1107.htm (756 words)

	Section 21CFR312.3 (Site not responding. Last check: 2007-11-06)
		For purposes of this part, ``IND'' is synonymous with ``Notice of Claimed Investigational Exemption for a New Drug.'' Investigational new drug means a new drug or biological drug that is used in a clinical investigation.
		Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.
		The sponsor does not actually conduct the investigation unless the sponsor is a sponsor- investigator.
	edocket.access.gpo.gov /cfr_2002/aprqtr/21cfr312.3.htm (550 words)

	History of Research
		The result was the passage of the 1906 food and drug law that legislated that drugs must be proved and tested to be "pure" prior to their being available for sale to the public at large.
		An investigation showed that not only was research being done on patients without who had not given informed consent, but also that research was being done on patients who had expressly refused consent.
		The New York Times reported she died because of failure of scientists and administrators to recognize that the experiment was unsafe.
	www.drugstudy.md /resource3.html (3933 words)

	Investigational New Drug Application Under Review by FDA: Xyrem for Fibromyalgia
		The Company also announced that it has filed an Investigational New Drug (IND) Application to begin a clinical trial to assess Xyrem in the treatment of fibromyalgia syndrome.
		The Food and Drug Administration (FDA) has received the application and has begun its statutory review of the IND. The Company expects to initiate the trial during the second quarter of 2004.
		As previously announced, there were a total of 2,738 prescriptions filled in the last six-weeks bringing the total to 5,087 in the first-quarter of 2004.
	www.immunesupport.com /library/showarticle.cfm/ID/5610 (812 words)

	EPA: Federal Register: Paclitaxel Drug Products; Environmental Information Needed in New Drug Applications, Abbreviated ... (Site not responding. Last check: 2007-11-06)
		SUMMARY: The Food and Drug Administration (FDA) is issuing this document to clarify the environmental information that must be submitted to the Center for Drug Evaluation and Research (CDER) for drug products containing paclitaxel.
		Paclitaxel is an active moiety that may be obtained or derived from various wild or cultivated species of yews.
		Under the National Environmental Policy Act (NEPA), all Federal agencies are required to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses.
	www.epa.gov /fedrgstr/EPA-IMPACT/1996/November/Day-18/pr-17153.html (1024 words)

	2000 CFR Title 17, Volume 3 (Site not responding. Last check: 2007-11-06)
		General requirements for use of an investigational new drug in a clinical investigation.
		Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
		Drugs for investigational use in laboratory research animals or in vitro tests.
	www.access.gpo.gov /nara/cfr/waisidx_00/21cfr312_00.html (87 words)

	Raven Biotechnologies: News & Resources: Press Releases: November 16, 2004 Raven biotechnologies Files First ... (Site not responding. Last check: 2007-11-06)
		SOUTH SAN FRANCISCO, NOVEMBER 16, 2004 -- Raven biotechnologies, inc. announced today the submission of an Investigational New Drug Application (IND), seeking permission from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for RAV12, a therapeutic monoclonal antibody (MAb), in patients with advanced stage adenocarcinoma.
		The Phase 1, open-label, dose-escalation clinical trial for RAV12 in patients with adenocarcinomas is planned to begin enrolling patients after IND activation by the FDA.
		Raven biotechnologies, inc. (www.ravenbio.com) is a privately held biotechnology company focused on the simultaneous discovery of novel cell-surface drug targets and the antibody therapeutics to regulate them.
	www.ravenbio.com /Nov16.04.html (487 words)

	DepoMorphine Investigational New Drug Application Filed
		A lipid-based formulation, DepoFoam is nontoxic and biodegradable, and has been shown to date to be well-tolerated in patients.
		When injected into the body, DepoFoam provides sustained release of the active drug which allows for less requent dosing.
		Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.
	www.docguide.com /dg.nsf/PrintPrint/9FAC8C4B59649D80852563FC006CBA6C (464 words)

	Competitive Technologies, Inc. - Press Releases - Competitive Technologies, Inc.'s Licensee Files Investigational New ... (Site not responding. Last check: 2007-11-06)
		The release was made in conjunction with a presentation at the January 11, 2000 Chase H&Q Health Care Conference.
		RPI's January 11, 2000 press release stated: "If the FDA approves the IND, the initial clinical study will consist of a safety and pharmacokinetic study in normal volunteers followed by a second study in HCV-infected, treatment-naïve patients.
		The second study will be a multi-dose clinical study designed to examine safety, pharmacokinetics and the extent of HCV RNA reduction in the blood.
	www.competitivetech.net /pr_000113.htm (549 words)

	AAMC: Chronic Cannabis Use in the Compassionate Investigational New Drug Program (Site not responding. Last check: 2007-11-06)
		Most Americans are unaware that the United States Government has had a "compassionate use" Investigational New Drug (IND) program that has provided medical cannabis to patients for nearly 30 years.
		Ethan Russo and co-authors express their astonishment that virtually no research has ever been conducted or published on IND program participants.
		It is the authors’ opinion that the Compassionate IND program should be reopened and extended to other patients in need of clinical cannabis.
	www.letfreedomgrow.com /cmu/chronic_cannabis_use.htm (964 words)

	DepoMorphine Investigational New Drug Application Filed (Site not responding. Last check: 2007-11-06)
		SAN DIEGO—Dec. 9, 1996 -- DepoTech Corp. (NASDAQ:DEPO) Monday announced that is has filed an Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration to begin a Phase I clinical trial of DepoMorphine, a sustained-release DepoFoam formulation of morphine used to treat acute post-surgical pain.
		The company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this release.
		Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.
	www.pslgroup.com /dg/eafa.htm (375 words)

	Notice to Readers: Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol
		In 1997, an equine DAT product manufactured by Pasteur Merieux (Lyons, France) was made available in the United States through a Food and Drug Administration (FDA)--approved Investigational New Drug (IND) protocol ( 2).
		U.S. physicians caring for patients with suspected respiratory diphtheria can obtain DAT by contacting the diphtheria duty officer at CDC's Bacterial Vaccine Preventable Disease Branch in the Epidemiology and Surveillance Division of the National Immunization Program (telephone, 404-639-8257) from 8 a.m.
		Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
	www.cdc.gov /mmwr/preview/mmwrhtml/mm5319a3.htm (574 words)

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