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(HHS: Washington) -- Designed to advance collaboration within the quality measurement community and to synchronize measurement, the Department of Health and Human Services (HHS) has developed an inventory of quality measures that are used for reporting, payment, or quality improvement by its…
(Commonwealth Fund: New York) -- How do patients feel about the care they receive in U.S. hospitals? A study in the October 30 New England Journal of Medicine, supported by the Commonwealth Fund, shows that while patients are generally satisfied with their care, satisfaction levels aren't as high…
(FDA: Rockville, Maryland) -- To learn about the development of global initiatives to ensure the integrity of the Pharmaceutical Supply Chain, join regulatory and industry representatives from at the PDA-FDA Pharmaceutical Ingredient Supply Chain Conference, December 3-5, 2008 at Loews…
(HHS: Washington) -- As part of an ongoing strategy to address the food safety issues in China and the United States, and to share ideas to address global food safety, the U.S. Food and Drug Administration (FDA) opened its first office in Beijing, China, on Nov. 19, 2008. The U.S. Department of…
(HHS: Washington) -- Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through more than 300 ports of entry. All projections indicate that this volume will continue to rise sharply over the coming years as the scale and complexity of…
(The Joint Commission: Oakbrook Terrace, Illinois) -- Beginning Jan. 1, 2009, under a new Joint Commission policy, laboratory accreditation decisions will no longer immediately affect hospital accreditation decisions. This policy establishes comparability in the way that a laboratory with an…
(Centers for Medicare and Medicaid Services: Washington, D.C.) -- As the beginning of the annual election period for the Medicare Prescription Drug Program nears, many seniors and their caregivers are in the dark about how the program works and how to make the most of it. This is something Esther…
(Press Ganey Associates Inc.: South Bend, Indiana) -- By analyzing patient satisfaction data representing 1.5 million patients and 1,158 hospitals across the nation from January 2007 through June 2008, Press Ganey Associates Inc. found a dramatic upturn in patient satisfaction, strengthening the…
(AHRQ: Rockville, Maryland) -- The Patient Safety and Quality Improvement Act (Patient Safety Act) authorized the creation of patient safety organizations (PSOs) to improve safety through the collection and analysis of data on patient safety events. By providing privilege and confidentiality, PSOs…
(National Quality Forum: Washington, D.C.) -- To support consumer engagement and improved quality in health care, the National Quality Forum (NQF) endorsed guidelines for consumer-focused, internet-based public reporting. These guidelines will assist report sponsors to present information about…
(FDA: Rockville, Maryland) -- In a bid to extensively modernize the Food and Drug Administration’s (FDA’s) data management, data warehousing, information technology (IT) infrastructure, and IT security, FDA has awarded 10 contractors a total of $2.5 billion to implement the FDA’s Information…
(FDA: Rockville, Maryland) -- Due to quality control problems at two Ranbaxy Laboratories Ltd. manufacturing plants in India, the U.S. Food and Drug Administration (FDA) issued two warning letters and an import alert for generic drugs produced by the company.
“With this action we are sending a…
(Best Practices LLC: Chapel Hill, North Carolina) -- Within the hospital marketplace, pharmaceutical and biotechnology salespeople must negotiate increasingly complex organizational and decision-making structures to effectively represent their brands. Hospital formulary decisions are not only…
(Medco Health Solutions Inc.: Franklin Lakes, N.J.) -- Noting that the United States spends twice as much per capita on health care as most other developed nations, but achieves no better clinical outcomes, Medco Health Solutions Inc. chairman and CEO, David B. Snow, Jr., unveiled a…
(HHS: Washington, D.C.) -- The Chartered Value Exchanges (CVEs) is a growing movement to build a health care system where consumers, providers, and payers make decisions based on the value and quality of care. Currently, there are 25 local collaborations of health care providers, employers,…
(FDA: Dallas, Texas) -- The U.S. Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates (SoCRA), is holding a conference on FDA Clinical Trial Requirements Regulations, Compliance, and GCP. This two-day program for the clinical…
(Drug Information Association: Horsham, Pennsylvania) -- The Drug Information Association (DIA), in collaboration with the U.S. Food and Drug Association (FDA), the Medical Imaging Contrast Agent Association, the Council on Radionuclides and Radiopharmaceuticals, and the American Medical…
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in pre-market reviews of medical devices. The FDA Modernization Act of 1997 authorized the agency to recognize voluntary consensus standards developed…
(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting…
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational…
(ASPEX: Pittsburgh, Pennsylvania) -- Following the U.S. Food and Drug Administration’s recent decision to join European and Australian authorities in the inspection of overseas drug manufacturing facilities, the pharmaceutical industry is re-examining its approach to quality control. In response…
Poor records and poor management of good records can trigger needless costs, penalties, and public embarrassment for Food and Drug Administration-regulated companies. As if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records…
(AHRQ: Rockville, Maryland) -- Potentially preventable medical errors that occur during or after surgery may cost employers nearly $1.5 billion a year, according to new estimates by the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ).
In a study…
(CMS: Baltimore, Maryland) -- The Centers for Medicare and Medicaid (CMS) announced payment of more than $36 million in bonus payments to many of the more than 56,700 health professionals who satisfactorily reported quality information to Medicare under the 2007 Physician Quality Reporting…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) issued a final regulation that makes early phase-1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational…