GFda Information Artical FDA Says A BIG NO. Find out WHY Background and some few Clarifications of some definitions by FDA: Dietary Supplement: A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet which includes: vitamins, minerals, herbs or other botanicals, amino acids, and substances such
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.
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
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
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
An article by Alan Schwartz and George Ye
By: Alan P. Schwartz Should Industry be Accepting? HACCP, what are you talking about? Why would the FDA want to use it for inspecting medical device manufacturers? But why is the FDA now looking to implement a policy that was strictly used for the food industry, for the medical industry? If I am correct, I
By Alan P. Schwartz Change for the sake of change is not always a good thing. But when change can be beneficial to all parties involved, getting mutual agreement on change may be easier and actual implementation faster. Such could be the case with proposed new good manufacturing practices (GMP) for the medical product manufacturing
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