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(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…
(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…
(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…
(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…
(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…
(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.…
(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…
