Book 1SP: SPANISH LANGUAGE
2013 Selected FDA Regulations & ICH Guidelines
for Clinical Studies for US Drug Approval

  Description        Contents         Book Cover        How to Order

Table of Contents

• CFR Title 21:  Food and Drugs (Revised as of April 1, 2013)
       Parts  11    Electronic Records/Electronic Signatures
                 50    Protection of Human Subjects
                 54    Financial Disclosure
                 56    Institutional Review Boards
                 312  Investigational New Drug Application

• ICH Guidelines
       E6     Good Clinical Practice