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FDA Drug Approval Process
Pre-Clinical
DRUG DEVELOPED
A sponsor develops a new drug compound and seeks to have it

A Brief Guide to the

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ug ed r D lop ve e D

approved by the FDA for sale in the United States.

ANIMALS TESTED
A sponsor must test a new drug on animals for toxicity. Multiple species are used to gather basic information on the safety and efficacy of the compound being investigated and researched.

ls a m i An ed t s e T

INVESTIGATIONAL NEW DRUG (IND) APPLICATION
The sponsor submits an IND application to the FDA based on the results from the initial testing. The IND also includes a plan for testing the drug on humans. The FDA reviews the IND to assure that the proposed studies/clinical trials do not

DATA L A C I N I L C ING S U O H E R WA

place human subjects at unreasonable

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Investigational New Drug (IND) Application

risk of harm. The FDA also verifies that there are adequate informed consent and human subject protection.

Clinical
Phas eI
PHASE I
Approximately 20-80 healthy volunteers participate in a phase I clinical trial. This phase emphasizes safety and the goal is to determine what the drug’s most frequent side effects are and how the drug is metabolized and excreted.

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PHASE II

II

Hundreds of patients participate in a phase II clinical trial. This phase emphasizes effectiveness and the goal is to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled clinical trials, patients receiving the

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as

drugs are compared to similar patients

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receiving a different treatment, usually a

III

placebo or a different drug. Safety continues to be evaluated and short-term side effects are studied. At the end of this phase, the FDA and sponsor discuss how large-scale studies in a phase III clinical trial will be conducted.

Revie Meet w i with ng FDA

PHASE III

ANALYTICS

Thousands of patients participate in a phase III clinical trial. The purpose of this phase is to gather more information about safety and effectiveness, study different populations and different dosages, and the use of the drug in combination with other drugs.

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NDA Application

NDA Review
REVIEW MEETING

n Applicatio Reviewed

detecting and managing
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The FDA meets with a sponsor prior to the submission of a New Drug Application (NDA).

NDA APPLICATION
The drug sponsor formally asks the FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data, the analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

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APPLICATION REVIEWED
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, the FDA review team is assigned to

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y t i l i c a F n o i t c e Insp
ECLINICAL

evaluate the sponsor’s research on the drug’s safety and effectiveness.

DRUG LABELING
The FDA reviews the drug’s professional labeling and assures appropriate information is communicated to healthcare professionals and consumers.

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Drug Appr ova l

FACILITY INSPECTION
The FDA inspects the facilities where the drug will be manufactured.

DRUG APPROVAL
The FDA will approve the application or issue a response letter.

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Post-Marketing
as eI V
PHASE IV
Once the FDA approves a drug, the post-marketing stage begins. The sponsor is required to submit periodic safety updates to the FDA. The objective of the updates is to monitor the serious adverse events related to the drug and take action when necessary.

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SAFETY AND PHARMACOVIGILANCE

Sources: www.fda.gov; www.oracle.com; www.fas.org; www.hhs.gov

Learn how Oracle’s clinical and pharmacovigilance applications can help your organization throughout the various clinical trial phases today!