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The European Union is working to make products safer for consumers and manufacturers alike. Its new regulations concerning chemicals used in product makeup, REACH, will extend across the pond to affect chemical standards in the United States. The new legislation will make everything from the…
(FDA: Silver Spring, Maryland) -- The U.S. Food and Drug Administration (FDA) recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds…
Baldrige award medallion.
(NIST: Gaithersburg, MD) -- Seventy organizations have taken the first step toward the 2009 Malcolm Baldrige National Quality Award, the nation’s highest recognition for innovation and performance excellence.…
(InfinityQS: Chantilly, Virginia) -- ProFicient 4 includes new enhancements and features to further help you improve quality and drive down costs. ProFicient 4 focuses on compliance reporting (useful for companies in regulated industries or companies who need to meet customer specifications), an…
(IBS: Lexington, Massachusetts) -- IBS, the global leader in enterprise quality and compliance solutions, today announced the latest release of CompliantPro, its web-based quality management software. CompliantPro 7.2 features increased platform support in product infrastructure as well as…
(FDA: Silver Spring, Maryland) -- The Food and Drug Administration (FDA) recently issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and…
(FDA: Salt Lake City)—Utah-based life science companies are being implored to utilize a scientific approach to regulatory compliance, and to keep the lines of communication open with the Food and Drug Administration. FDA district director Tom Warwick recently spoke with hundreds of life-science…
(Aegis Corp.: Lafayette, Colorado) -- Recent deployment of manufacturing process intelligence software “Discoverant,” from Aegis Analytical Corp., enables life science manufacturers to apply the updated principles and approaches for process validation outlined in the United States Food and Drug…
(Project on Emerging Technologies and Food and Drug Law Institute: Washington) -- In 2007, the global market for goods incorporating nanotechnology totaled $147 billion. Lux Research projects that figure will grow to $3.1 trillion by 2015.
Is the Food and Drug Administration (FDA) equipped to…
(Food and Drug Law Institute: Washington) -- To help organizations stay in compliance with Food and Drug Administration (FDA) regulations, the Food and Drug Law Institute is hosting the “Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug…
(FDA: Rockville, Maryland) – In light of recent peanut butter and peanut products recalls, and to help ensure the safety of regulated products in the supply chain, the Food and Drug Administration (FDA) issued three guidances that include the following:
Final guidance for industry on "…
(ISPE: Tampa, Florida) – The International Society for Pharmaceutical Engineering, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, will hold the 2009 Tampa Conference at the Grand Hyatt Tampa Bay in Tampa, Florida, March 2–5.
Among the many…
(FDA: Rockville, Maryland) -- In an effort to combat counterfeiting and contamination, the Food and Drug Administration (FDA) is launching a voluntary pilot program for drug makers to determine the practicality of developing a secure supply chain program.
The goal of the program is to allow the…
(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…