Module 1 2021

IND Application

• IND Content

− Electronic submission required − eCTD format

• Form FDA 1571 − Contains the signature of the Sponsor or the Sponsor’s authorized representative • Form FDA 3674: Certification of compliance • Form FDA 1572: Statement of Investigator (for all participating sites)

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IND: Scientific Technical Sections

Chemistry, Manufacturing & Controls

Pharmacology & Toxicology

Microbiology

Drug Regulatory Application

Human Pharmacokinetics and Bioavailability

Clinical

Statistics

Typical IND for a NCE:

~ 2,800 – 3,200 pages

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