FDA Issues First New Rules Under Food Safety Modernization ActRules to prevent potentially unsafe food from reaching consumers
Thu, 05/05/2011 - 12:27
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new… FDA, EMA Announce Pilot for Parallel Assessment of Quality by Design ApplicationsQbD pilot addresses ICH guidelines being interpreted differently in Europe and the United States
Thu, 03/24/2011 - 09:09
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as… FDA, EMA Announce Pilot for Parallel Assessment of Quality by Design ApplicationsQbD pilot addresses ICH guidelines being interpreted differently in Europe and the United States
Thu, 03/24/2011 - 09:09
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as… FDA, Justice Department Slam McNeil-PPC Inc.J&J subsidiary charged with making and selling OTC drugs in violation of federal law
Tue, 03/15/2011 - 08:46
(U.S. FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) announced that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current Good Manufacturing… FDA’s Transparency Initiative Revealed at New Website FDA Basics for Industry helps regulated industries save time and resources
Thu, 01/13/2011 - 13:53
(FDA: Silver Spring, MD) — The U.S. Food and Drug Administration (FDA) has introduced a new web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes… FDA, USDA, Cornell University Join Forces for Produce SafetyAim is to help produce growers, packers access food safety educational materials
Mon, 11/08/2010 - 14:07
(FDA: Silver Spring, MD) -- A public-private organization will provide produce growers and packagers with fundamental, on-farm food safety knowledge, in advance of a proposed produce safety regulation, the U.S. Food and Drug Administration (FDA),… FDA Takes Steps to Increase Safety of Foods During TransportAgency poised to set new safety standards for the transportation of food in commerce; provides new guidance.
Fri, 04/30/2010 - 11:53
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) is asking commercial food transporters to follow new guidance the agency issued to reduce the chances of physical, chemical, biological, and other risks during… FDA Seeks Public Comments on Increasing Transparency With Regulated IndustryElectronic or written comments deadline is April 12.
Mon, 03/15/2010 - 14:07
(FDA: Washington) -- As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration (FDA) is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its… FDA Issues Guidance to Help Streamline Medical Device Clinical TrialsAgency says Bayesian statistical methods could trim costs, boost efficiency.
Fri, 02/05/2010 - 14:35
(FDA:Washington) -- The U.S. Food and Drug Administration (FDA) has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies… Harvard Pilgrim to Develop FDA Pilot for Safety Monitoring SystemSentinel System will bolster the FDA’s efforts in monitoring product safety.
Tue, 01/12/2010 - 13:19
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA’s Sentinel System, which will use automated health care data to evaluate medical product…
