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Chapter Three: 6. Discuss federal Food and Drug Administration (FDA) regulation of new drugs.

Chapter Three: 6. Discuss federal Food and Drug Administration (FDA) regulation of new drugs.

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FDA is a agency of united States health department to check the safety of food products,tobacco,dietary products,over the counter drugs, cosmetics, animal food etc.FDA has his head quarters at white oak, maryland.

In June 2018,they put forward some new guidelines to help them i.e to implement potential attack on us food supply.The guideline was to regulate intentional adulterations rule.This i directly leads to reduce in risk of compromise in facilities and processess.

A new drug goes under extensive scrutiny before getting FDA approval called New Drug Approval(NDA).New drugs are obtained by proper prescription and over the counter status is a separate process and need approval of NDA first.Certain exception has to under go multi step process including animal testing and clinical trials following certain protocols.New drug test may last long as it undergo more stages and number of individual increases from stage 1 to stage 3 over periods of years and involves drug companies,schools and medical clinic, government approved institution etc.The above mentioned process will be closely monitored.

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