The FDA drug approval process consists of 4 phases: pre-clinical testing on animals, clinical trials with humans (phases I-III), submission of a New Drug Application including all data, and post-marketing safety monitoring if approved. Phase I involves initial safety testing on 20-80 people. Phase II expands to hundreds of patients to preliminarily assess effectiveness. Phase III involves thousands of patients to further evaluate safety and effectiveness in various populations. If approved after review of the application and manufacturing facilities, the drug is monitored post-market for adverse events.

1. A Brief Guide to the
FDA Drug
Approval Process
1 Pre-Clinical
Drug
Approval
DRUG DEVELOPED
A sponsor develops a new drug
compound and seeks to have it
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.
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
place human subjects at unreasonable
risk of harm. The FDA also verifies that
there are adequate informed consent
and human subject protection.
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 fre-
quent side effects are and how the drug
is metabolized and excreted.
PHASE II
Hundreds of patients participate in a
phase II clinical trial. This phase empha-
sizes effectiveness and the goal is to
obtain preliminary data on whether the
drug works in people who have a cer-
tain disease or condition. For controlled
clinical trials, patients receiving the
drugs are compared to similar patients
receiving a different treatment, usually a
placebo or a different drug. Safety con-
tinues 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.
PHASE III
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 dos-
ages, and the use of the drug in combi-
nation with other drugs.
2 Clinical
Facility
Inspection
Phase IV
Application
Reviewed
Drug
Labeling
3 NDA Review
REVIEW MEETING
The FDA meets with a sponsor prior to
the submission of a New Drug Applica-
tion (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 be-
haves in the body and how it is manu-
factured.
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
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 infor-
mation is communicated to healthcare
professionals and consumers.
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.
NDA
Application
Drug
Developed
Animals
Tested
Investigational
New Drug (IND)
Application
Phase I
Phase II
Phase
III
4 Post-Marketing
PHASE IV
Once the FDA approves a drug, the
post-marketing stage begins. The spon-
sor 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.
Review
Meeting
with FDA
CLINICAL DATA
WAREHOUSING
Do you have a
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What systems
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clinical trials?
How are you
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managing
drug safety
signals?
and
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PV operations?
ANALYTICS
ECLINICAL
SAFETY AND
PHARMACOVIGILANCE
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Sources: www.fda.gov; www.oracle.com; www.fas.org; www.hhs.gov
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fact-based
insight
into your
clinical programs?