The 505(b)(2) pathway provides an accelerated timeline to approval for a wide range of new drug applications involving already approved drug molecules.
The key to a viable 505(b)(2) New Drug Application (NDA) development strategy is identifying existing submission gaps early, and then planning for studies that will effectively bridge those gaps. Algorithme Pharma offers scientific guidance in developing a clinical study design to address critical endpoints such as safety, pharmacokinetics and pharmacodynamics in accordance with 505(b)(2) regulatory criteria.
Algorithme Pharma has recently conducted more than 50 clinical trials for multiple 505(b)(2) targeted filings, where several have received Food and Drug Administration (FDA) approvals. Our most recent audit, in March 2013, successfully met all requirements in the FDA inspection of our clinical, bioanalytical and phamacokinetics units. With high quality 505(b)(2) trial conduct and individualized clinical program guidance, Algorithme Pharma continues to support sponsors in successfully navigating this development pathway.