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Notice of claimed investigational exemption

Figure 7.1 Information supplied to the CVM in support of a Notice of Claimed Investigational Exemption (NCIE) for an Investigational New Animal Drug (INAD). Figure 7.1 Information supplied to the CVM in support of a Notice of Claimed Investigational Exemption (NCIE) for an Investigational New Animal Drug (INAD).
Once a drug is judged ready to be studied in humans, a Notice of Claimed Investigational Exemption for a New... [Pg.102]

In the United States, the federal FD C Act and its amendments require that a manufacturer demonstrate the safety and efficacy of a new drug prior to introducing it into interstate commerce. The requirements are clearly spelled out in the Notice of Claimed Investigational Exemption for a New Drug (IND) and the NDA. [Pg.7]

See other pages where Notice of claimed investigational exemption is mentioned: [Pg.135]    [Pg.630]    [Pg.523]    [Pg.98]    [Pg.157]    [Pg.720]    [Pg.1406]    [Pg.151]    [Pg.21]    [Pg.37]    [Pg.214]    [Pg.402]    [Pg.991]    [Pg.135]    [Pg.630]    [Pg.523]    [Pg.98]    [Pg.157]    [Pg.720]    [Pg.1406]    [Pg.151]    [Pg.21]    [Pg.37]    [Pg.214]    [Pg.402]    [Pg.991]    [Pg.258]    [Pg.78]    [Pg.211]   


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Claims

Exemptions

Notice

Notice of Claimed

Notice of Claimed Investigational

Noticing

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