¶ … Drug Development (From Nature to the Market)
The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process, as it proceeds from nature to the market.
Drugs that eventually make it to the marketplace can come from a variety of sources -- plants, animals, microbes, synthetic chemistry, biotechnology, and even modified molecules. Years of research and billions of dollars are invested by pharmaceutical companies as they seek out new, potential drugs for the market. All of this effort has resulted in the FDA's approval of 1,200 drugs for the marketplace since 1950 (Munos 960). The "recipes" that have gone into producing these drugs are diverse, with some changing over time in order to meet with continuingly reassessed standards and updated regulations. While drugs have been produced by societies around the world through all history, the 20th century saw the beginning of a vast, federal initiative to provide oversight of the drug industry for the first time in the U.S. This began with the Food and Drug Act in 1906 -- the 1st law to be passed at the federal level regarding the regulation of drug standards. Various Acts throughout the 20th century amended the statutes contained in this early piece of legislation -- such as the F.D. & C. Act in 1938, the Durham-Humphrey Amendment in 1952, and the Kefauver-Harris Amendments in 1962 (all of which were passed to address issues that arose in the marketplace regarding safety of dispensation, safety of the drugs themselves, and authenticity of the drug's claims).
Today, new drugs must be sponsored in order to obtain FDA approval. Drug companies are typically the ones to sponsor new pharmaceuticals and as the sponsors, they are responsible for providing evidence that the new product is safe, effective, and does as is indicated by the product description. Moreover, as a result of the development of regulations in the industry, drug companies must also follow protocols regarding the manufacturing, packaging,...
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