Resources

198 Resources for

Federal Government

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FDA Loosens Rules for Overseas Drug Trials: Merrill Goozner, a former Chicago Tribune reporter turned public-health advocate (he heads up the Integrity in Science Project at the Center for Science in the Public Interest), notes an interesting and almost wholly overlooked Food and Drug Administration decision that may have the effect of subjecting clinical-trial volunteers in poor...; Tags: FDA, Drug, Gist, Federal Government, Government, David P. Hamilton; Blog posts 2008-05-08
Astra Takes on Glaxo in U.S. COPD Drug Market: By Ben Hirschler LONDON (Reuters UK) - AstraZeneca is seeking U.S. approval to sell its asthma drug Symbicort for chronic obstructive pulmonary disease (COPD), ramping up competition with GlaxoSmithKline's Advair. Both are inhaled drugs combining a corticosteroid and a long-acting beta-agonist. AstraZeneca said on Wednesday...; Tags: AstraZeneca Plc., FDA, Astra, Symbicort, Federal Government, Government, Oukbs; News items 2008-04-30
Cholesterol-drug Rejection Rips New Gash in Merck: By Ransdell Pierson NEW YORK (Reuters) - Confidence in Merck & Co's (MRK) earnings prospects withered on Tuesday, along with its stock price, after U.S. regulators surprisingly rejected the drugmaker's treatment to raise levels of "good" HDL cholesterol. Shares of Merck,...; Tags: Financial accounting, Merck & Co. Inc., vaccine, earnings, analyst, cost control, Thomson Reuters Corp., DJIA, New York, U.S., CEO, sales, manufacturing, strategy; News items 2008-04-29
FDA to New Drugs: It's Hammer Time: Wonder no further whether the recent litany of drug-safety problems would make the Food and Drug Administration more cautious about approving new drugs. In just the past four days, the agency has thrown some serious sand into the industry's drug-development works, delaying or derailing three separate programs of widely varying...; Tags: FDA, Agency, Merck & Co. Inc., Cordaptive, Federal Government, Government, David P. Hamilton; Blog posts 2008-04-29
Glaxo Wins U.S. FDA Approval For Wider Advair Use: By Susan Heavey WASHINGTON (Reuters UK) - U.S. health regulators have said GlaxoSmithKline Plc's (GSK)(GSK) Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease (COPD), the drugmaker said on Wednesday. Glaxo's approval comes the same day as rival AstraZeneca...; Tags: AstraZeneca Plc., FDA, Patient, Glaxo, Advair, Federal Government, Government, GlaxoSmithKline Plc.; News items 2008-04-30

News May Need Waiver to Acquire Newsday: Rupert Murdoch's plan to add Long Island's Newsday newspaper to his News Corp empire likely will become the next lightning rod in a debate over how US regulators decide on the number of media properties one company can own.If News Corp tries to buy Newsday, the company may ultimately...; Tags: FCC, Newsday, Consolidation, Waiver, Media Ownership, Federal Government, Government, REUTERS; News items 2008-04-24
Chinese Eye $15b Electricity Sell-off: China's largest power company is eyeing the NSW government's $15 billion sell-off of the electricity industry.China Huaneng Group has already bought power assets in Queensland and Singapore, Fairfax reports, and now wants to greatly expand its presence in South-east Asia and Australia.The company has asked its "Australian team to...; Tags: Australian Associated Press Pty Ltd., Chinese Company, Government, Federal Government, Asset Management, Team Management, Vertical Industries, Operational Planning, Business Operations, Management, Enterprise Software, Software, AAP; News items 2008-05-09
Zuckerman Submits $580 Million Newsday Bid: Source: By Robert MacMillan and Kenneth Li NEW YORK (Reuters) - New York Daily News owner Mortimer Zuckerman has submitted a $580 million bid for Tribune Co's Newsday daily newspaper on Long Island, New York, matching a bid by News Corp (NWSa) Chief Executive...; Tags: Newsday, Tribune Co., Rupert Murdoch, News Corp., television station, New York, Thomson Reuters Corp., FCC, CEO, back-office, TV, banking, agreement, tax, phone, industry; News items 2008-04-26
Why Biogenerics Will Survive Genzyme's Problems: The Food and Drug Administration rejected Genzyme's request to sell a version of its drug Myozyme made in a new factory, a decision some journalists and bloggers insist on casting as a black mark against the very notion of generic biotech drugs. There's just one problem: These...; Tags: FDA, Genzyme Corp., Clinical Trial, Biotech Drug, WSJ Health Blog, Biotech Industry, Biotechnology, Federal Government, Government, David P. Hamilton; Blog posts 2008-04-22
FDA to Prescribe New Drug Manufacturing Standards: U.S. Food and Drug Administration (FDA) caught many drug makers by surprise when it announced a broad-ranging initiative to overhaul how it regulates pharmaceutical manufacturing operations. The announcement comes at a time when a significant number of major drug makers have struggled to meet the FDA's current Good Manufacturing Practices...; Tags: Federal government, FDA, manufacturing; White papers
Meeting US FDA 21 CFR Part 11 Requirements: The U.S. Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health. MetricStream, the leading provider of compliance and...; Tags: Federal government, HEALTHCARE, MetricStream Inc., FDA, regulation, life science, quality management, public health, compliance, software; White papers
SCORE Helps Technical Consultant Open Doors To New Markets: Shirley Young was among the thousands of entrepreneurs who successfully rode the wave of the global technology boom. Her company, Global Advanced Technology, Inc. (GATI), provided engineering and management services to some of the nation's leading telecommunications and networking and fault-tolerant computing companies, and served as the U.S. distributor for...; Tags: fault-tolerance, consulting, telecommunications, computer, network; Case studies
Automation's Double-Edged Sword: The same drive toward automation and digital control that has transformed modern manufacturing is reshaping the pharmaceutical production world. At one level, Food and Drug Administration (FDA) addresses this by requiring validation of control and information systems that interact with production, the same as it does for reactors or tableting...; Tags: Federal government, FDA, information system, manufacturing, industry, software; White papers
Small-Business Freebies From The Government: The federal government doesn't just collect taxes and look over our shoulders at our business practices. It has a number of organizations that actually help business. The old joke goes this way: We're from the government, and we're here to help you. But the truth is, the federal government really...; Tags: Microsoft Corp., federal government, small business, tax, agency, Internet; White papers
Armed Forces Recreational Center Uses Federal Government ESPC to Achieve Goals: Shades of Green is a 216,050 square foot resort facility with 287 rooms. The resort is operated by the United States Army for the benefit of active and retired military personnel. Shades of Green is located at the Walt Disney World Resort. The project objective is to reduce operating costs,...; Tags: American Standard Inc., support services, benefit; Case studies
Thermal Storage Retrofit Reduces Costs for Federal Building: This 27-story structure is located in downtown Pittsburgh and was constructed in 1963. A wide range of federal government agencies occupies the building. The original 30-year old chiller plant consisted of two 990-ton centrifugal chillers equipped with open drives and reduction gears. By modern standards, the chillers were of comparatively...; Tags: American Standard Inc., storage system, storage; Case studies
Waiving Informed Consent: Military Use of Non-FDA-Approved Drugs in Combat: The 1991 Gulf War raised a number of ethical and policy questions regarding the use of investigational drugs to defend against chemical and biological warfare (CW/BW) agents. Historically, the Department of Defense (DoD) has agreed to comply with all civilian Food and Drug Administration (FDA) regulations concerning the development and...; Tags: Federal government, RAND Corp., FDA, pharmaceutical company, vaccine, agent; White papers
Systems Validation for 21CFR Part 11 Compliance: 21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. FDA issued a very comprehensive guidance on systems validation in a document released in January 2002. This white paper uses...; Tags: Federal government, MetricStream Inc., FDA, software development, best practice, audit, compliance, software; White papers
Case Study: Taking a Chassis to the FCC B Standard: Cost-effectively modifying a chassis from FCC Class A to Class B illustrates various areas of technical concern. The techniques involve intelligently balancing the shielding, cooling and performance of the chassis while only making relatively minor sheet metal changes. The challenges of packaging electronic hardware to ensure electromagnetic compatibility (EMC) continue...; Tags: Federal government, FCC, technique, hardware, performance; Case studies
Expiring Terrorism Insurance Act Threatens to Leave Businesses Exposed: The federal government's agreement to back companies that offer terrorism insurance expires at the end of the year, bringing the prospect of sky-high premiums and scarce coverage for local companies in 2006. The Terrorism Risk Insurance Act, or TRIA, was enacted three years ago in the wake of Sept. 11...; Tags: Homeland security, Corporate insurance, Regulations, American City Business Journals Inc., terrorism insurance, Terrorism Risk Insurance Act, terrorism, insurance company, insurance, Sept. 11, terrorist attack, agreement; White papers