All News
(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…
(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…
(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…
(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…
(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…
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration is seeking a $2.2 million penalty against a California hearing device manufacturer, Advanced Bionics LLC and its president and co-CEO, Jeffrey H. Greiner, for violations of federal law, including manufacturing standards…
(CBI: Woburn, Massachusetts) -- As the Food and Drug Administration continues to increase their monitoring of adverse events and product complaints, it’s even more critical for quality assurance departments to stay current on best practices and benchmark with peers. CBI’s sixth annual Product…
(NSF International: Ann Arbor, Michigan) – The 2008 version of NSF’s American National Standard for Dietary Supplements now includes new good manufacturing practices (GMP) requirements to ensure consistency with the U. S. Food and Drug Administration’s regulations. The new version of NSF/ANSI…
(HHS: Washington, D.C.) -- The U. S. Department of Health and Human Services stated that efforts are underway between the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) to improve patient safety and the quality of medical care.“This initiative will…
(Research and Markets: Dublin, Ireland) – A Frost & Sullivan research service titled “Automation and Control Solutions in the European Pharmaceutical Market” provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and…
(Washington, D.C.) — Republican senator Chuck Grassley of Iowa has asked for an independent assessment of how the Food and Drug Administration (FDA) follows up on the effects of medicines that it approves based on narrowly defined benefits.“The way things have turned out with drugs like…
(Zimmer Holdings Inc.: Warsaw, Indiana) -- Zimmer Holdings Inc. has recently taken a number of actions to improve quality systems at its Dover, Ohio, facility, which manufactures Zimmer Orthopedic Surgical Products (OSP). Zimmer recently conducted a review of quality systems at the Dover, Ohio…
CRO Completes Multinational Training Program for Principal Investigators from China, Duke University
Lisa Mazurka and the clinical investigators involved in the training is available (Clinical Research Consulting Inc.: Boston, Massachusetts) -- Clinical Research Consulting Inc., a contract research organization (CRO) specializing in clinical monitoring…
(Pharmaceutical Technology Magazine: Iselin, New Jersey) – QPEC’s Annual Quality and Process Excellence Conference will be held from July 21-23 at the Westin Arlington Gateway in Arlington, Virginia. The conference is sponsored by Pharmaceutical Technology Magazine. This case study-driven…
(UCSF: San Francisco) -- The approval process for medical devices doesn’t involve the same rigorous review used for pharmaceuticals, and to improve health outcomes this needs to change, say researchers from the University of California, San Francisco.In the January 2008 issue of the Journal of…