Question

After reviewing the FDA’s guidance on expedited programs for serious conditions, discuss the pros and cons of priority review and accelerated approval programs.

Answer 1

Pros of priority review and accelerated approval programs

1. It is very fast and it approves drugs that are used for diseases that does not have any prior treatment

2. Very useful for the pandemic infections since they can kill people at a faster rate

3.facilitate the discovery and marketing of drugs targeted for serious or rare diseases and to accelerate the approval of molecules showing superior efficacy than the existing one.

Cons :

1. The drugs released using fast review for the need of society may have undefined side effects since the time for process is not given.

2. Sometimes the immune modulating effect of drugs are not studies