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Drug Approval ProcessDrug Approval Process

Developing a new drug is a timeDeveloping a new drug is a time--consuming, expensiveconsuming, expensiveprocess that often requires up to 10 years.process that often requires up to 10 years.

The process begins with laboratoryThe process begins with laboratory

experiments resulting in the synthesis andexperiments resulting in the synthesis andpurification of a possible new drug.purification of a possible new drug.

The compound then goes through a series of tests inThe compound then goes through a series of tests inanimal and human subjects to determine if it is safeanimal and human subjects to determine if it is safe

and effective against disease.and effective against disease.

When those studies are completed, the Food andWhen those studies are completed, the Food andDrug Administration (FDA) decides whether toDrug Administration (FDA) decides whether to

approve the drug for sale in the United States.approve the drug for sale in the United States.

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DRUG APPROVAL PROCESSDRUG APPROVAL PROCESS

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SYNTHESIS AND PURIFICATIONSYNTHESIS AND PURIFICATION

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ANIMAL TESTINGANIMAL TESTING

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PHASE 1PHASE 1 CLINICAL TRIALCLINICAL TRIAL

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PHASE 2PHASE 2 CLINICAL TRIALCLINICAL TRIAL

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PHASE 3PHASE 3 CLINICAL TRIALCLINICAL TRIAL

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REVIEW AND APPROVALREVIEW AND APPROVAL