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Notice of Claimed Investigational Exemption for a New Drug

Table 1 Components of a Notice of Claimed Investigational Exemption for a New Drug (IND)... [Pg.634]

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 for a New Drug is mentioned: [Pg.630]    [Pg.523]    [Pg.98]    [Pg.157]    [Pg.720]    [Pg.1406]    [Pg.151]    [Pg.21]    [Pg.37]    [Pg.214]    [Pg.402]    [Pg.630]    [Pg.523]    [Pg.98]    [Pg.157]    [Pg.720]    [Pg.1406]    [Pg.151]    [Pg.21]    [Pg.37]    [Pg.214]    [Pg.402]    [Pg.135]    [Pg.991]    [Pg.258]   
See also in sourсe #XX -- [ Pg.402 ]



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Claims

Drugs, new

Exemptions

Notice

Notice of Claimed

Notice of Claimed Investigational

Noticing

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