a brief guide to the fda drug approval process

Download A Brief Guide to the FDA Drug Approval Process

Post on 03-Apr-2018

213 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • 7/28/2019 A Brief Guide to the FDA Drug Approval Process

    1/1

    A Brief Guide to the

    FDA Drug

    Approval Process1 Pre-Clinical

    DrugApproval

    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)

    APPLICATIONThe 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 isto determine what the drugs 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 aphase 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

    PhaseIV

    Application

    Reviewed

    Drug

    Labelin

    g

    3 NDA ReviewREVIEW MEETINGThe 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 sponsors research on the

    drugs safety and effectiveness.

    DRUG LABELING

    The FDA reviews the drugs 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

    Deve

    loped

    Animals

    Tested

    InvestigationalNew Drug (IND)

    Application

    PhaseI

    PhaseII

    PhaseIII

    4 Post-MarketingPHASE 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

    MeetingwithFDA

    CLINICALDATA

    WAREHOUSING

    Do you have a

    validated andsecure repository

    for your safety, clinical,

    and non-clinical data?

    What systemsare you using to

    clinical trials?

    How are you

    detecting

    managingdrug safety

    signals?

    and

    Have you considered

    Argus Safetyto help manage your

    PV operations?

    ANALYTICS

    ECLINICAL

    SAFETY AND

    PHARMACOVIGILANCE

    Learn how Oracles clinical and pharmacovigilance applications can

    help your organization throughout the various clinical trial phases today!

    manage your

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

    Do you have

    fact-based

    insightinto your

    clinical programs?