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For thousands of years drugs have been produced to cure diseases and ailments of all different types Drugs are produced to relieve pain kill microorganisms regulate metabolic processes alter the state of mind and to sedate patients as needed in hospitals For quite a long time drugs were used entirely at the doctors discretion often without need of any outside approval Early beginnings of drug regulations began in 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act into law This law prohibited alterations of food and drugs as well as mislabeling and false advertising of food and drugs to consumers as phony elixirs and tonics were very often sold by people for profit Later the Food and Drug Administration FDA was formed and regulations were soon created and became effective Drugs are often produced by companies that specialize in creating them such as AstraZeneca Merck Co and Bayer Healthcare for example Other times they may be developed in research facilities educational institutions and other private organizations In order for a drug to be introduced into the United States drug market for approved use the entities that created them must submit a new drug application NDA to the Food and Drug Administration The FDAs Center for Drug Evaluation and Research abbreviated as CDER is in charge of evaluating new drugs for safety and effectiveness The 1938 Food Drug and Cosmetic Act 2009 Creators of new drugs are responsible for running tests on their drugs and submitting the results to CDER for review A panel of health professionals pharmacists and scientists review the NDA for the new drug and use their expertise to pass judgment on whether or not it is suitable for common use The FDA is required to approve drugs to ensure that the drug the manner in which it is used for what conditions it is used and how much of it is used are safe to treat patients However
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