This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2), the pathway of choice. When executed properly, this regulatory pathway enables a lower cost, lower risk, and faster path to approval and market. Because no two 505(b)(2) NDAs are alike, the strategy laid out at the beginning is paramount to success.
Focusing on three recent cases, this webinar will present common missteps along with strategies to achieve success, including:
- Misconceptions in developing products with common and known active ingredients
- Challenges differentiating a product to gain Orphan Drug Designation
- Formulation difficulties with improved delivery technologies
These case examples provide insights into why 505(b)(2) is the regulatory pathway of choice for advancing medicines.