505(b)(2) Bridging Studies
While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.
Gene Therapy
Nonclinical Considerations for Gene Therapy Products
The development of a gene therapy (GT) product has many considerations that differ from those of a traditional biologic or new chemical entity (NCE) program.
Current Gene Therapy Landscape: Overview, Challenges, and Benefits
What is gene therapy? With over 450 gene therapy and gene-based medicine companies worldwide and around 800 gene therapy and gene-modified cell therapy clinical trials being conducted, it’s time to find out.