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Regulatory Insights

Collaborate and Innovate!

Currently, the United States is the world’s leader in Medical Device innovation.  The pace of innovation continues to increase rapidly.  However, the development, clinical testing, and review/approval process required by Title 21 is lengthy, expensive, and can be seen as an impediment to the pace of advancements of medical technology. While the United States leads […]

FDA, Transparency and Market Place Improvement

In June 2009 the Federal Drug and Administration (FDA) responded to President Obama’s commitment to promote transparency and openness in the government by launching an internal Transparency Initiative.  The Initiative’s objective was to develop mechanisms that would promote the disclosure of information online to the public. Toward this end, the U.S. FDA created a task […]

ICH and FDA: A Valuable Cooperative

In the interest of promoting public health and safety, one of the U. S. Federal Drug Administration’s (FDA) continual goals is to foster the advancement of the global harmonisation of regulatory requirements and practices.  The relationship between the FDA and the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human […]

FDA, Transparency, and Consumer Protection

Most people are aware that the FDA is a federal agency and its mission is to protect the health and safety of the American public.  What many people fail to realize is that FDA inspectors are federal agents.  FDA agents are sworn into duty, taking an oath to protect health and human safety.  Since its […]

FDA’s Attempts to Implement Continual Improvement Efforts & The 2011 Budget

The Food and Drug Administration, an administration within the Health and Human Services division of the executive branch of the United States federal government, is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary […]

Agribusiness and Governmental Oversight

In May, the Centers for Disease Control identified a nationwide increase in the number of salmonella cases documented in the United States.  Approximately three months later Wright County Egg voluntarily conducted a nationwide recall of shell eggs from three of its five farms. The recall was expanded to all Wright County Egg farms on Aug. […]

One Year Anniversary of Tobacco Control Act

In 2009 the United States Congress completed a long rumored expansion of Title 21.  This was manifested via the Family Smoking Prevention and Tobacco Control ACT (Tobacco Control ACT), which was codified into law last year(1).  This article will review the purpose of the ACT, reflect on the actions taken in the past year, and […]

FDA: Improving Strategy for Ensuring Integrity of Clinical Data

Clinical data management is generally understood to mean a process of implementing a reliable method for collecting, processing, managing, and conveying data in a manner that protects subjects’ rights, and insures data integrity.  Historically, regulations intended to ensure the integrity of clinical data are contained within 21 CFR 312. The ability to falsify data is […]

Gulf Spill, Industrial or Governmental Failure?

In the last few weeks (57 days) an overwhelming amount of information has been pouring into the media with regard to British Petroleum’s deep water rig explosion. As a Quality Systems professional, whose job it is to assure the control of processes and the eventual outcome of them, I wanted to do my own research […]

The USFDA Launches Initiative to Reduce Infusion Pump Safety Risks

The U.S. Food and Drug Administration has announced a new initiative to address what FDA’s Center for Devices and Radiological Health (CDRH) has referred to as “rampant” safety issues associated with the technology utilized by external infusion pumps. CDRH Director Jeffrey Shuren has called this a first for the agency, exercising its authority over an […]