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(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…
(FDA: Rockville, Maryland) -- The Food and Drug Administration is seeking volunteers from pharmaceutical companies to participate in a pilot quality-by-design (QbD) program.
The purpose of the program is to gain more information in the areas of chemistry, manufacturing, and controls, and to…
The U.S. Food and Drug Administration (FDA) is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration’s “Food Protection Plan Progress Report,” in conjunction with the “Interagency Working Group on Import Safety Action Plan Update,” shows significant areas of activity to further improve the safety of America’s food supply since…
(NCQA: Washington, D.C.) -- The National Committee for Quality Assurance recently released its 2007 annual report, “Coming Home to Better Care.” The report looks at the promise of the patient-centered medical home, a promising approach that seeks to strengthen the patient-physician relationship…
(Quality Digest: Chico, California) -- Be sure to check out the new, fully redesigned Quality Digest homepage and web site. Not only is the new site more aesthetically pleasing than ever, it’s easier to navigate, so you can now find your favorite topics, columnists, departments, and articles…
(IBM: Armonk, New York) -- IBM’s vision statement, "Healthcare 2015 and Care Delivery: Delivery models refined, competencies" defined calls for collaboration among providers to achieve new milestones in defining, measuring and delivering value across national and global health care systems.
The…