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BGR-34 (Blood Glucose Regulator-34) [1] is an Ayurvedic-derived product that is sold in India as an over-the-counter pill for the management of type 2 diabetes. It was developed in 2015 by two government-owned laboratories and launched commercially in 2016. It has been tested in only one, modest-sized, human trial. [2]
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The FCC has been published since 1966. Before 1960s, although the federal Food and Drug Administration (FDA) had by regulations and informal statements defined in general terms quality requirements for food chemicals generally recognized as safe (), these requirements were not published in the official regulations or designed to be sufficiently specific, therefore their use for general ...
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An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. [2] The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958 , and all additives introduced after this time had to be evaluated ...
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Between the 1930s and 1990s there had been a guideline minimum rate for sampling for chemical analysis (not including samples for microbiological examination) of 2.5 samples per annum per 1000 head of population, however that was an arbitrary figure and more recent thinking suggested that the selection of a frequency for sampling should be ...
[citation needed] Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name company, including advertising, presentations by drug representatives, and distribution of free samples. Many drugs introduced by generic manufacturers have already been on the market for a decade or more and may already be ...