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(GAO: Washington) – The Food and Drug Administration (FDA) was added to the U.S. Government Accountability Office (GAO) biennial update list of federal programs, policies, and operations that are at “high risk” for waste, fraud, abuse, and mismanagement, or in need of broad-based transformation…
(FDA: Rockville, Maryland) -- To protect domestic and imported food from contamination, the U.S. Food and Drug Administration (FDA) launched its Food Protection Plan in 2007. Now, the FDA has issued “The One-Year Summary of Progress under the Food Protection Plan,” which describes FDA’s…
(Drug Information Association: Horsham, Pennsylvania) -- The Drug Information Association (DIA) will host its eighth annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies, January 11–15 in Washington, D.C. This annual event addresses current complexities and…
(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…
(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…
(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…
