Biotech Values

[dewophile]

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