CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Administrative Record<br />
•Paper trail documenting the decision making<br />
process and basis for the decision<br />
•Copies of Telecons, FAXes, Review Memos,<br />
Meeting Minutes, etc., become part of the<br />
administrative record and are entered into the<br />
file and the tracking system<br />
C<br />
E<br />
B<br />
R