FDA Consulting Services
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Food
The Bio-terrorism Act directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. FDA established regulations requiring that; Food facilities register with […]
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Drug
The FD&C Act defines drugs, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.FDA requires manufacturers, re-packers, and re-labelers that engage in the manufacture, […]
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Medical Devices
You must follow the steps below prior to marketing a medical device in the United States:Step One: Classify Your Device Step Two: Choose the Correct Premarket Submission Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during […]
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Cosmetics
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, […]
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