Two former Synthes Inc. executives were sentenced to nine months in prison and a third sentenced to five months in prison for their roles in the medical-device maker’s promotion of bone cement for unauthorized uses. U.S. District Court Judge Legrome Davis sentenced Michael D. Huggins, who was chief operating officer of Synthes, and Thomas B.
Letter to Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami
Japan is a critical participant in the global medical device market. on March 11, 2011, a massive earthquake and tsunami occurred near the northeastern coast of Japan, followed by various aftershocks, causing extensive damage to this region. The United States Food and Drug Administration (FDA) regrets any destruction or loss caused by this unforeseen disaster.
Rockland County Department of Health, Rockland, NY urges all residents not to use products known to contain lead The Rockland County Department of Health announces that there were two recent New York City adult lead poisoning cases that have been associated with the use of Ayurvedic medicines manufactured and purchased in India. The products used
Food recalls across the United States seemed to be everyday news last year. Eggs, beef, tuna and lettuce just to name a few-were all recalled at one time or another for a variety of reasons. Recent year, lawmakers hope new legislation will eventually make food recalls rare news events. President Obama signed the Food Safety
mdi Consultants Inc. to anchor turnkey solution for companies building U.S. presence DALLAS – December, 2010 – Market Center Management Company, the management company of leading trade centers and trade events around the world, today announced the creation of a Global Business Development Center within the Nashville Medical Trade Center, opening in 2013. The 5,000
Food Services Update: September, 2010 Many food suppliers and/or manufactures are being brought into the 21 Century. For the past 30 years the pharmaceutical and medical device industries had to comply with a whole set of complex regulatory requirements both from the US FDA and/or foreign governments. There is the FDA cGMPs, FDA QSR/cGMP, ISO
The FDA has now approved new regulations pertaining to the registration of Institutional Review Boards. SUMMARY: The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information
Article for the Chinese agency, CCUS (Certification Center International Standards) by Alan Schwartz Recently, we participated in a seminar on United States (US) Food and Drug Administration (FDA) regulations to the Hebei Pharmaceutical Association in Shijianzhuang, the capital city of the Hebei province. This seminar was presented by CCUS, (Chinese Committee for US Standards) a
An FDA Veteran Describes What You Need to Know Before Working With a New Outsourcing Partner Alan Schwartz, Contributing Writer The medical device industry is a very dynamic one, with new companies being set up constantly—bringing either new, unique devices or better designed me-too products to market on a regular basis. Most of these companies
A requirement of ISO13485 (2003) by the Japanese Government authorities for medical devices in Japan. We recently obtained information from our Japanese affiliate concerning ISO13485 and what the future requirements will be by the Japanese Governments for medical device suppliers’ exporters. This information will be very important for any company that is presently exporting medical