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These excerpts taken from the STEM 10-K filed Mar 16, 2009. U.S.
Regulations
In the United States, pharmaceuticals, biologicals and medical
devices are subject to rigorous regulation by the U.S. Food
and Drug Administration (FDA). The Federal Food, Drug and
Cosmetic Act, the Public Health Service Act, applicable FDA
regulations, and other federal and state statutes and
regulations govern, among other things, the testing,
manufacture, labeling, storage, export, record keeping,
approval, marketing, advertising, and promotion of our potential
products. Product development and approval within this
regulatory framework takes a number of years and involves
significant uncertainty combined with the expenditure of
substantial resources. In addition, many jurisdictions, both
federal and state, have restrictions on the use of fetal tissue.
Table of Contents
U.S. Regulations In the United States, pharmaceuticals, biologicals and medical devices are subject to rigorous regulation by the U.S. Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act, the Public Health Service Act, applicable FDA regulations, and other federal and state statutes and regulations govern, among other things, the testing, manufacture, labeling, storage, export, record keeping, approval, marketing, advertising, and promotion of our potential products. Product development and approval within this regulatory framework takes a number of years and involves significant uncertainty combined with the expenditure of substantial resources. In addition, many jurisdictions, both federal and state, have restrictions on the use of fetal tissue.
Table of ContentsThese excerpts taken from the STEM 10-K filed Mar 14, 2008. U.S.
Regulations
In the United States, pharmaceuticals, biologicals and medical
devices are subject to rigorous regulation by the U.S. Food
and Drug Administration (FDA). The Federal Food, Drug and
Cosmetic Act, the Public Health Service Act, applicable FDA
regulations, and other federal and state statutes and
regulations govern, among other things, the testing,
manufacture, labeling, storage, export, record keeping,
approval, marketing, advertising, and promotion of our potential
products. Product development and approval within this
regulatory framework takes a number of years and involves
significant uncertainty combined with the expenditure of
substantial resources. In addition, many jurisdictions, both
federal and state, have restrictions on the use of fetal tissue.
U.S. Regulations In the United States, pharmaceuticals, biologicals and medical devices are subject to rigorous regulation by the U.S. Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act, the Public Health Service Act, applicable FDA regulations, and other federal and state statutes and regulations govern, among other things, the testing, manufacture, labeling, storage, export, record keeping, approval, marketing, advertising, and promotion of our potential products. Product development and approval within this regulatory framework takes a number of years and involves significant uncertainty combined with the expenditure of substantial resources. In addition, many jurisdictions, both federal and state, have restrictions on the use of fetal tissue. | EXCERPTS ON THIS PAGE:
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