Tag: FDA generic drugs

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The FDA uses priority and standard review timelines to speed up or delay generic drug approvals. Priority review, at 8 months, goes to first generics, shortage drugs, or medically improved versions. Standard review takes 10 months. A new U.S. manufacturing pilot now boosts priority status for drugs made domestically.

Dissolution Testing: How FDA Ensures Generic Drug Quality

The FDA uses dissolution testing to ensure generic drugs release active ingredients at the same rate as brand-name versions, avoiding costly human trials while guaranteeing therapeutic equivalence. This science-based method is key to safe, affordable generics.