DRUG DISCOVERY DEVELOPMENT (DDD): 1 In NDA, if Deficiencies are noted - __

2 Once resolved -

3 Companies hold __

Question

1 In NDA, if Deficiencies are noted - __

2 Once resolved -

3 Companies hold __

LEIGHTON DWIGHT OBILLOS · Accepted Answer

1 a LETTER is SENT TO SPONSOR

2 company must PROVIDE WRITTEN
CERTIFICATION and FDA will CLEAR the application
WITHIN 45 days if corrections are adequate

3 mock pre-approval audits

1 In NDA, if Deficiencies are noted - 2 Once resolved - 3 Companies hold