[Logo - CDER] CHEMISTRY REVIEW TEMPLATE
[Logo - CDER] |
Chemistry Assessment Section
TABLE OF CONTENTS
Table
of Contents
....................................................................................................... |
2 |
Chemistry Review Data Sheet
...................................................................................... |
4 |
The Executive Summary
.............................................................................................. |
8 |
I. Recommendations
..................................................................................
.............................................. |
8 |
A. Recommendation
and Conclusion on Approvability
............................................................................ |
8 |
B. Recommendation on
Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable
......................................................................................................................... |
8 |
II. Summary of Chemistry Assessments
...................................................................................................... |
8 |
A. Description of
the Drug Product(s) and Drug Substance(s) ................................................................ |
9 |
B. Description of
How the Drug Product is Intended to be Used
............................................................. |
9 |
C. Basis for Approvability
or Not-Approval Recommendation
................................................................. |
10 |
III. Administrative
....................................................................................................................................... |
10 |
A. Reviewer’s
Signature
...................................................................................................................... |
10 |
B. Endorsement Block
.......................................................................................................................... |
10 |
C. CC Block
........................................................................................................................................ |
10 |
Chemistry Assessment
................................................................................................ |
11 |
I. DRUG SUBSTANCE
...........................................................................................................................
|
11 |
1. Description &
Characterization
......................................................................................................... |
11 |
a. Description ................................................................................................................................. |
11 |
b.
Characterization /Proof of Structure
............................................................................................. |
11 |
2. Manufacturer
................................................................................................................................... |
13 |
3. Synthesis /
Method of Manufacture ................................................................................................... |
13 |
a. Starting
Materials – Specs & Tests
.............................................................................................. |
13 |
b. Solvents,
Reagents, etc.
............................................................................................................... |
15 |
c. Flow Chart .................................................................................................................................. |
17 |
d. Detailed
Description
.................................................................................................................... |
18 |
4. Process Controls
.............................................................................................................................. |
18 |
a. Reaction
Completion / Other In-Process Tests .............................................................................. |
18 |
b. Intermediate
Specs & Tests
......................................................................................................... |
19 |
5. Reference Standard
.......................................................................................................................... |
19 |
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