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Information Sheet for Clinical Laboratory Testing
Learn more about
Clinical Laboratory Testing
.
Presentations:
First Regulatory Education Seminar
Feigal - Regulations for Medical Device Development
Grudzinskas - Drug Development Decision Points
Kessler - The Federal Regulation of New Drugs
Lee - Role of Academic Investigators in Drug Development
Peck - Role of FDA in Guiding Drug Development
Second Regulatory Education Seminar
Lee - Introduction
Peck - Preclinical Data Package for IND Submission
Savello - Chemistry, Manufacturing, and Controls of Drug Candidates for Dummies
Sheevers - How Much Animal Data are Required to Move into Clinical Testing?
Lee -Choosing a Dose for the First-Time-In-Human Study
Forms:
FDA Form 1571 (IND)
FDA Form 1572 (Investigator)
