FDA |
|
The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States.
|
GMP - GOOD MANUFACTURING PRACTICES |
|
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs).
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the production and laboratory testing environment itself. An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product is considered contaminated (in the US considered adulterated).
|
MEDICAL |
|
Medical - Having to do with or anything pertaining to Medical treatment, Medical Malpractice, Medical review, Medical Litigation.
Find MEDICAL experts and consultants for MEDICAL litigation support. Available to be MEDICAL expert witnesses and provide MEDICAL forensic consulting in MEDICAL litigation, in addition prepare MEDICAL expert witness reports for use in deposition and/or in-court trial testimony.
|
MEDICAL DEVICES |
|
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
as defined by the US FDA.
|
PHARMACEUTICAL LITIGATION |
|
Thousands of people die from or are seriously injured by prescription and over-the-counter drugs each year. Patients trust these defective drugs will not harm them because they have been approved by the U.S. Food and Drug Administration or been prescribed by doctors or pharmacists they know and trust.
|
PRODUCT SAFETY |
|
The Consumer Product Safety Commission (CPSC) is an independent agency of the U.S. federal government created in 1972 through the Consumer Safety Act to protect against unreasonable risks of injuries associated with consumer products. As of 2005 its chairman is Hal Stratton, a Republican. The two other commissioners on the three-member board are (as of February 2006) Thomas Hill Moore (Democrat) and Nancy Nord (Republican).
|
|