PRA worked with an emerging biotech firm to implement a first-in-human clinical trial using a live biotherapeutic product for a rare disease indication.
Decoding FDA Gene Therapy Guidances Part Two: Rare Disease
In Part Two of Decoding FDA Gene Therapy Guidances, we discuss three separate guidances that provide further insight into how sponsors can safely and…
PRA Health Sciences Investor Relations
Decoding FDA Gene Therapy Guidances Part Three: Long-term Follow-ups
In Part Three of our Decoding FDA Gene Therapy Guidances series, we discuss the need for thorough long-term follow-up studies for these products, as…