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(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…
(American Society for Quality: Milwaukee, Wisconsin) -- Physician profiles are becoming an integral part of hospital appointment, reappointment, and ongoing professional practice evaluation (OPPE) as now required by The Joint Commission. A free seminar scheduled for Wednesday, July 30, 1-2 p.m…
(American Society for Quality: Milwaukee, Wisconsin) -- The American Society for Quality has submitted guidelines to the Office of Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services in response to a concern about a ruling that could threaten to…
(Octagon Research Solutions Inc.: Wayne, Pennsylvania) -- Octagon Research Solutions Inc., a provider of software and services to the life sciences industry, has announced a new service offering, CheckPoint. The new service provides more than 300 separate validation checks of electronic…
The parties are meeting on the week of June 23 in Annapolis, Maryland, as part of the fourth session under the United States-China strategic economic dialogue (SED).
“Today's progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products…
(HHS: Washington, D.C.) -- Efforts are underway at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) to improve patient safety and the quality of medical care through a plan called “The Sentinel Initiative—A National Strategy for Monitoring Medical…
(The Joint Commission: Oakbrook Terrace, Illinois) -- The Joint Commission recently announced the 2009 National Patient Safety Goals and related requirements for each of its accreditation programs and its Disease-Specific Care Certification Program.
The National Patient Safety Goals promote…
(ISO: Geneva) -- A new edition of ISO 9001 is being submitted for voting as a final draft international standard. Subject to formal approval by the ISO membership, the publication of the revised version is expected to be published this fall.
The proposed ISO 9001:2008 doesn’t introduce additional…
(HHS: Washington, D.C.) -- Efforts are underway at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) to improve patient safety and the quality of medical care through a plan called “The Sentinel Initiative—A National Strategy for Monitoring Medical…
(HHS: Washington, D.C.) -- U.S. Secretary of Health and Human Services (HHS) Mike Leavitt has signed a joint progress statement with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China.…
(Octagon Research Solutions Inc.: Wayne, Pennsylvania) -- Octagon Research Solutions Inc., a provider of software and services to the life sciences industry, has announced a new service offering, CheckPoint. The new service provides more than 300 separate validation checks of electronic…
(NCQA: Washington, D.C.) -- The Quality Crossroads Group, a group of stakeholders drawn together to identify strategies to address the complex challenges confronting the United States health care system, recently proposed a five-point agenda that examines quality in patient safety, the…
(Medtral: Auckland, New Zealand) -- With a growing number of international medical travelers concerned about hospital accreditation, Medtral New Zealand, a health care organization based in New Zealand that coordinates medical travel packages from North America, addresses some of the pressing…