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Nda Process
Nda Process
• Full drug marketing application submissions under 21 CFR subpart 314.50 and
314.54 should be directed to:
Center for Drug Evaluation and Research
Food and Drug Administration
Document and Records Section
5901-B Ammendale Rd
Beltsville, Md. 20705-1266
7. How is the sponsor notified regarding the outcome of their drug evaluation
by the CDER?
a. The sponsor is sent one of three possible action letters from the CDER after
the review process is complete
i. Not Approval Letter
1. Lists deficiencies in application
2. Explanation of disapproval
ii. Approvable Letter
1. The drug can be approved
2. Lists minor deficiencies
3. Post-approval studies
iii. Approval Letter
1. The drug is approved
b. Regardless of issued action letter the sponsor has an opportunity to meet
with the CDER agency upon request
8. NDA Actions
a. Once the action letter recommendation is decided by the reviewers and
supervisors the decision must be evaluated and agreed on by the director of the
drug review division.
b. The consumer safety officer assembles an “action package” which includes
i. The action letter
ii. Any data
iii. CDER reviews and memos
c. Final FDA ruling
i. Division director usually has the ‘sign-off’ of such drugs
ii. Class I drugs require a office level (above division director) ‘sig-off’
iii. After the approval action letter is signed by the division or office
director the product can be legally marketed starting that day in the United
States