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  4. FDA Guidelines

FDA Guidelines

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  • FDA GMP Guidelines

    The U.S. Food and Drug Administration establishes quality guidelines for food, drugs, medical devices and biologics. These quality guidelines are called good manufacturing practices. GMPs are law under the Federal Food, Drug, and Cosmetic Act.

  • FDA Method Validation Guidelines

    The FDA validation process is designed to make sure a product has been produced according to its specifications and fulfills its intended purpose. It is a quality control system that makes sure a product is of high quality. There are a couple of guidelines on what the process should look like.

  • ICH Guidelines by the FDA

    The FDA requires clinical drug studies be carried out in accordance with the standards of the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (mercifully abbreviated to ICH). Consisting of a joint commission of drug regulatory officials from Europe, Japan and the United States, the ICH reviews scientific and technical aspects of drug testing. The ICH strives for more economical use of resources and fast-tracking of important new medicines through its guidelines, which fall into four major categories: quality, safety, efficacy and multidisciplinary.

  • FDA Meat Guidelines

    To protect consumers and distributors of meat, the U.S. Food and Drug Administration recommends that several steps be taken in the storing and preparation of meat, including proper sanitation, refrigeration, separation and preparation. The FDA has also warned meat producers about using too many additives.

  • FDA Serving Size Guidelines

    FDA serving size regulations help consumers compare and contrast the value of the food they are purchasing and ensure they are getting the nutrition they and their families need.

  • FDA Guidelines for Foreign Material

    The U.S. Food and Drug Administration defines foreign matter in food as "objectionable matter" such as sticks, cigarette butts and inedible parts of a plant like a stem or pit.

  • FDA Food Guidelines for Expirations & Best Before Dates

    An expiration date is a guide to the consumer stating the last date that a food item can be consumed before it is considered spoiled. This date is usually expressed on the food item's label. The Food and Drug Administration has no specific guidelines for food apart from baby formula.

  • FDA Guidelines for Bioequivalence

    The FDA guidelines for bioequivalence have been established to ensure primarily that generic drug manufacturers are producing drugs equivalent to the non-generic versions. The requirements are also in place to ensure the drugs are as safe and work as well as brand-name medicines.

  • FDA Guidelines for Aseptic Processing

    The Food and Drug Administration is the agency that oversees the manufacturing and production of food and medicines to ensure they are made in a safe manner. The guidelines for aseptic processing are challenging and must be followed to ensure the entire process is completed in a sterile manner as opposed to simply confirming sterility of the final product.

  • FDA Stability Guidelines

    Stability test guidelines established by the Food and Drug Administration help to govern drug-testing conditions. The FDA provides these guidelines as recommendations to researchers to test new and experimental drugs under equal conditions to other established drugs.

  • FDA Guidelines for Diabetic Diets

    The Food and Drug Administration (FDA) provides specific guidelines designed for diabetic needs. Because obesity and diabetes are on the rise in the United States, the federal government is weighing in on these serious and related health issues. One of the signature elements of the FDA's guidelines is flexibility. Diabetics have options that match individual lifestyles. When meal plans are individualized, there is a greater chance that people will follow them.

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