DRUG DISCOVERY DEVELOPMENT (DDD): Drug approval

1 Approved:

2 NOT Approved:

3 Approvable:

Question

Drug approval

1 Approved:

2 NOT Approved:

3 Approvable:

LEIGHTON DWIGHT OBILLOS · Accepted Answer

1 the sponsor may now market the  product

2 the product may not be  marketed, provides detailed explanation of  the reasons for the decision

3 FDA is prepared to approve the  NDA after the sponsor rectifies identified  deficiencies and satisfies condition in the  complete response letter.

Drug approval 1 Approved: 2 NOT Approved: 3 Approvable: