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Topic: Regulatory

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In the News (Mon 7 Dec 09)

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Match Play

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Hugh Jackman

	Electronic Regulatory Submissions and Review - ERSR
		This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.
		With the implementation of the guidance for industry Providing Regulatory Submissions in Electronic Format – ANDAs (June 2002), the submission of these dataset records for use in the review should be in archivable format.
		Although electronic mail is in widespread use within CDER and within the regulatory industry, CDER has yet to adopt formal policies for accepting regulatory submissions or formal correspondences through electronic mail.
	www.fda.gov /cder/regulatory/ersr (2621 words)

	National Association of Regulatory Utility Commissioners (NARUC)
		The National Association of Regulatory Utility Commissioners (NARUC) urges that priority attention be given to the long-established, but slow moving plan to safely dispose of spent nuclear fuel from commercial nuclear power plants that continues to accumulate at 72 sites in 34 States that were never designed for indefinite long-term storage.....more
		On April 22, 2005, the President of the National Association of Regulatory Utility Commissioners (NARUC), Iowa Utilities Board Member Diane Munns, announced the appointments of several State utility commissioners to various positions.....more
		The Chair of the Electricity Committee of the National Association of Regulatory Utility Commissioners (NARUC), the Honorable Sam J. Ervin, IV, of the North Carolina Utilities Commission, has announced a forum between State Commissioners and members of the Federal Energy Regulatory Commission (FERC), along with appropriate members of their senior staffs....more
	www.naruc.org (514 words)

	GSA - Regulatory Information Service Center (Site not responding. Last check: 2007-10-21)
		The Regulatory Information Service Center facilitates the development of, and access to, information about federal regulatory and deregulatory activities.
		The Unified Agenda of Federal Regulatory and Deregulatory Actions is published in the spring and fall of each year.
		The Regulatory Plan, which is published as part of the fall edition of the Agenda, identifies regulatory priorities and contains additional detail about the most important significant regulatory actions that agencies expect to take in the coming year.
	www.gsa.gov /risc (193 words)

	Regulatory CD4+CD25+ cells reverse imbalances in the T cell pool of bone marrow transplanted TG{varepsilon}26 mice ...
		Regulatory CD4+CD25+ cells reverse imbalances in the T cell pool of bone marrow transplanted TG{varepsilon}26 mice leading to the prevention of colitis -- Veltkamp et al.
		T cells or may contribute to the absence of regulatory T cells
		or induction of regulatory T cells in the abnormal thymus is
	www.gutjnl.com /cgi/content/abstract/54/2/207 (289 words)

	Index of Regulatory Guidance Letters
		Regulatory Guidance Letters (RGL’s) were developed by the Corps as a system to organize and track written guidance issued to its field agencies.
		RGL’s are normally issued as a result of evolving policy; judicial decisions and changes to the Corps regulations or another agency’s regulations which affect the permit program.
		RGL’s are used only to interpret or clarify existing Regulatory Program policy, but do provide mandatory guidance to the Corps district offices.
	www.usace.army.mil /inet/functions/cw/cecwo/reg/rglsindx.htm (870 words)

	Regulatory Affairs Professionals Society (RAPS)
		Designed for mid-level professionals, this forum examines critial elements of a regulatory affairs strategy in an interactive setting.
		Showcase your expertise to nearly 10,000 RA colleagues worldwide by contributing an article to this leading regulatory publication.
		Regulatory Affairs Focus is a benefit of RAPS membership and is available to members online and by mail.
	www.raps.org (338 words)

	Applied Regulatory Consulting Ltd
		The regulatory environment for medicines is changing too, on a daily basis.
		To guide you through the global maze of regulatory challenges, Applied Regulatory Consulting provides a personalised expert service that focuses on how to best achieve your goals.
		To find out how we can help you, please contact us and we will be happy to provide you with further information about how we can support you with your particular project.
	www.appliedregulatory.com (163 words)

	FDA/SPRC/CFSAN Regulatory Fish Encyclopedia (RFE) Browse Page
		Lane Banding Pattern Peak Reports in the Regulatory Fish Encyclopedia resulting from Densitometry, Integration, and Migration Position Normalization (Position Calibration against pI Marker Standards) from use of the Standard RFE IEF Gel Format.
		The Regulatory Fish Encyclopedia (RFE) is a compilation of data in several formats that assists with the accurate identification of fish species.
		It was developed by FDA's RFE Team to help federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace.
	vm.cfsan.fda.gov /~frf/rfe0.html (4767 words)

	CATO INSTITUTE REGULATORY STUDIES
		Thus, the total regulatory burden might be as much as 10 percent of GDP.
		Under the direction of Edward Hudgins, Cato’s regulatory studies program sets forth a market-oriented vision of "regulatory rollback" that relies on the incentive forces of private property rights to create competitive markets and to provide consumer information and protection.
		Regulating the Regulators: Regulatory Reform in the 104th Cong.
	www.cato.org /research/reglt-st.html (1489 words)

	Role of Interferon Regulatory Factor-1 in Double-stranded RNA-induced iNOS Expression by Mouse Islets -- Blair et al. ...
		regulatory factor-1 (IRF-1), the activation of which is induced
		B and interferon regulatory factor-1 (IRF-1) are two transcription factors that participate in gene activation in response
		The abbreviations used are: IL-1, interleukin-1; dsRNA, double-stranded RNA; IFN, interferon; iNOS, inducible nitric oxide synthase; poly(I-C), polyinosinic-polycytidylic acid; IRF-1, interferon regulatory factor-1; TNF, tumor necrosis factor; LPS, lipopolysaccharide; NF, nuclear factor; STAT, signal transducers and activators of transcription; GAPDH, glyceraldehyde-3-phosphate dehydrogenase; PCR, polymerase chain reaction; RT, reverse transcription.
	www.jbc.org /cgi/content/full/277/1/359 (4636 words)

	State of Colorado-Department of Regulatory Agencies Home Page
		Equally important to DORA's mission is a responsibility to identify and recommend elimination of regulatory programs, statutes or rules that limit economic development and the efficient workings of a free market.
		Rule review and other functions of the Office of Economic Competitiveness and Regulatory Reform are now being performed by the Office of Policy, Research and Regulatory Reform.
		Questions and complaints concerning any of the individuals or businesses regulated by DORA agencies can be addressed either to DORA's Citizen Advocate or directly to the regulatory division, board or commission.
	www.dora.state.co.us (262 words)

	Cutting Edge: Contact-Mediated Suppression by CD4+CD25+ Regulatory Cells Involves a Granzyme B-Dependent, ...
		Cutting Edge: Contact-Mediated Suppression by CD4+CD25+ Regulatory Cells Involves a Granzyme B-Dependent, Perforin-Independent Mechanism -- Gondek et al.
		Regulatory Cells Involves a Granzyme B-Dependent, Perforin-Independent Mechanism
		Continuous control of autoimmune disease by antigen-dependent polyclonal CD4+CD25+ regulatory T cells in the regional lymph node
	www.jimmunol.org /cgi/content/abstract/174/4/1783 (344 words)

	Home
		The Regulatory Policy Institute (RPI) is an independent, charitable organisation dedicated to the study of all aspects of regulation and deregulation, including the institutional processes through which public policy is formed as well as the development, implementation, enforcement and impact of particular policies.
		It conducts research, publishes, and holds conferences and seminars.
		The Regulatory Policy Institute, 31-33 Westgate, Oxford OX1 1NZ, United Kingdom
	www.rpieurope.org (180 words)

	Small Business Administration: Office of Advocacy - Regulatory Comments, RFA, Regulatory Flexibility act
		Regulatory Comments for the Years 1996-2000 have been moved to the
		Letter dated 05/18/04 - Honorable Donald Manzullo, Chairman - Transmittal of the comments and nominations for regulatory reform sent to the OMB (5/14/04).
		The Office of Advocacy highlighted 30 regulations and guidance documents that are high priorities for reform to benefit small businesses.
	www.sba.gov /advo/laws/comments (4845 words)

	American Bar Association - Administrative Law News
		The Administrative and Regulatory Law News and the Administrative Law Review are published quarterly.
		The "News" keeps our members informed of recent developments affecting their clients and their practices with features such as Supreme Court News, News From the Circuits, News From the States and a review of Recent Articles of Interest.
		Browse the most recent issue of the "News" online or review back issues of the "News" for a discussion of court decisions, statutory and regulatory changes, or new articles or treatises you might have missed.
	www.abanet.org /adminlaw/news/backpage.html (129 words)

	Small Business Administration - Office of Advocacy - Regulatory Alerts
		Advocacy encourages affected small businesses to provide the Federal agency issuing the notice with comments on the proposed action and the agency's analysis of its potential impacts on small business.
		The Occupational Safety and Health Administration (OSHA) is conducting a review of its lead in construction standard under Section 610 of the Regulatory Flexibility Act and Section 5 of Executive Order 12866 on Regulatory Planning and Review.
		In 1993, in response to a statutory mandate to adopt a standard to protect construction workers from exposures to lead, OSHA promulgated a standard that requires testing of construction sites for lead exposures, as well as provisions to protect workers from exposure where lead is present.
	www.sba.gov /advo/laws/law_regalerts.html (1288 words)

	Welcome to South Carolina Office of Regulatory Staff
		The ORS is a state agency whose mission is to represent the public interest in utility regulation for the major utility industries -- electric, natural gas, telecommunications, water/wastewater, and transportation and railroad safety.
		You can access information on our role in the regulatory arena, our staff and their qualifications, each type of utility that we oversee, and much more.
		Please contact us if you have suggestions for making our web site more valuable to you.
	www.regulatorystaff.sc.gov (282 words)

	MHRA – Medicines and Healthcare products Regulatory Agency - Home page (Site not responding. Last check: 2007-10-21)
		Mandatory electronic individual case safety report (ICSR) reporting We are ready to begin testing electronic ICSRs with marketing authorisation holders.
		MLX 317: Consultation on the Review of EU Medicines Legislation (the '2001 Review') The responses and regulatory impact assessments of our consultation on the '2001 Review'.
		Patients across the UK to report suspected side effects from medicines through the Yellow Card Scheme We have launched a UK-wide pilot to enable patients to report suspected side effects from medicines.
	www.mhra.gov.uk (741 words)

	NRC: Students' Corner
		The electricity can then be carried to your home, so you can work on the computer, watch television, play video games, or make toast!
		The U.S. Nuclear Regulatory Commission, also called the “NRC,” regulates nuclear power plants.
		We make sure they are safe for people who work there and live nearby, and for the environment.
	www.nrc.gov /reading-rm/basic-ref/students.html (300 words)

	National Regulatory Research Institute
		The Research Clearinghouse for the National Association of Regulatory Utility Commissioners
		The NRRI was established by the National Association of Regulatory Utility
		Or Ask a Regulatory Expert who will find the information for you.
	www.nrri.ohio-state.edu (276 words)

	Therapeutic vaccination using CD4+CD25+ antigen-specific regulatory T cells -- Bluestone and Tang 101 (Supplement 2): ...
		of a professional regulatory T cell subset that has shown enormous
		be placed on approaches to exploit regulatory T cells either
		regulatory T cells (Tregs) was enhanced by the
	www.pnas.org /cgi/content/full/101/suppl_2/14622 (3919 words)

	Cutting Edge: TGF-{beta} Signaling Is Required for the In Vivo Expansion and Immunosuppressive Capacity of Regulatory ...
		Cutting Edge: TGF-{beta} Signaling Is Required for the In Vivo Expansion and Immunosuppressive Capacity of Regulatory CD4+CD25+ T Cells -- Huber et al.
		Signaling Is Required for the In Vivo Expansion and Immunosuppressive Capacity of Regulatory CD4
		Protection against Autoimmunity in Nonlymphopenic Hosts by CD4+CD25+ Regulatory T Cells Is Antigen-Specific and Requires IL-10 and TGF-{beta}
	www.jimmunol.org /cgi/content/abstract/173/11/6526 (418 words)

	:: Welcome to Taratec ::
		Technology breakthroughs, including genomics-based tests and analyses and micro-surgery techniques, contribute to early disease detection and replace and/or work in concert with drug-based treatment options.
		Reducing product development cycle time in RandD, improving overall product quality in manufacturing, and improving regulatory compliance in both areas are the dominant business issues facing life sciences RandD and quality control laboratories today.
		As the biotechnology industry matures, several companies now number among the largest in the life science sector.
	www.taratec.com (342 words)

	Office of Regulatory Services: Facility Location and Information Guide (Site not responding. Last check: 2007-10-21)
		Office of Regulatory Services: Facility Location and Information Guide
		Select one or more facility types from any one of the three categories below.
		Please note that Port 7001 must be open on your firewall if you wish to see the inspection reports.
	www.ors.dhr.state.ga.us (265 words)

	PLACE Home (Site not responding. Last check: 2007-10-21)
		PLACE is a database of motifs found in plant cis-acting regulatory DNA elements, all from previously published reports.
		Users are asked to cite the following article when publishing results, which have been obtained with the database described here.
		Reference: K. Higo, Y. Ugawa, M. Iwamoto and T. Korenaga (1999) Plant cis-acting regulatory DNA elements (PLACE) database:1999.
	www.dna.affrc.go.jp /htdocs/PLACE (353 words)

	21 CFR Part 11:Your FDA Compliance,Electronic Records, Electronic Signatures,cGMP and Meta Data Resource (Site not responding. Last check: 2007-10-21)
		Book: "Validation of Chromatography Data Systems - Meeting Business and Regulatory Requirements" by Bob McDowall
		FDA Issues Final Report on cGMPs for the 21st Century
		Electronic Common Technical Document (eCTD) and Your Regulatory Submissions Audio CD and transcript
	www.21cfrpart11.com (165 words)

	Telecommunications Regulatory Commission of Sri Lanka
		All TRCSL email addresses changed effective from 31
		The Telecommunications Regulatory Commission of Sri Lanka (TRCSL)
		Telecommunication Regulatory Commission of Sri Lanka, All Rights Reserved.
	www.trc.gov.lk (116 words)

	Advertising Standards Authority - Home
		Only half of the ads reviewed in this study that was undertaken by the ASA were found to satisfy the CAP Code, which contains specific rules regarding the advertisement of slimming products and services.
		In the third of our articles looking behind the scenes of the advertising regulatory system, ASA Agenda now turns its attention to the work of those in the Investigations teams.
		A step-by-step guide to what ASA can offer you:
	www.asa.org.uk (242 words)

	[No title]
		The mission of the PUC is to achieve a flexible regulatory environment that provides safe, reliable and quality services to utility customers on just and reasonable terms, while managing the transition to effective competition where appropriate.
		Customers facing much higher natural gas bills this winter.
		From here, viewers may click any of the buttons to the left to learn more about the PUC and its regulatory
	www.dora.state.co.us /puc (364 words)

	CAPRA/ACPR
		Canadian Association of Professional Regulatory Affairs (CAPRA) is a non-profit association dedicated to providing information and education for regulatory affairs professionals in the health-care industry in Canada.
		About CAPRA/ACPR - Board of Directors - Membership - Meetings - Employment - Feedback - Links - Advertisers - Admin
		Copyright © 2004 CAPRA - The Canadian Association of Professional Regulatory Affairs
	www.capra.ca (67 words)

	AdvaMed: Regulatory Issues - Comments
		AdvaMed comments regarding the process FDA used to identify reprocessed SUDs that will be required to submit validation date and making recommendations regarding additional products that should be required to submit validation data
		AdvaMed comments on new regulatory framework for IVD discussion paper proposed by Australian TGA
		AdvaMed comments on use of DEHP, related to California's Proposition 65
	www.advamed.org /publicdocs/comments-1.shtml (980 words)

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