Indeed, for truly simple issues, the FDA has created a telephone amendment pathway
i'm glad wedbush picked up on this point. from the FDA regs:
D. When is an amendment classified as a telephone amendment?3 If an amendment would otherwise be classified as minor, but the deficiencies are of a limited number or complexity, it can be classified as a telephone amendment (i.e. so the deficiencies in TEVA's application are NOT liminted in number or complexity)
it goes on to give some examples:
Such deficiencies include: 1. Clarification of data already submitted 2. Request for a postapproval commitment 3. Final resolution of technical issues, such as finalization of specifications