Uncategorized Resources

“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2)

“Breakthrough” the Barriers: Breakthrough Therapy Designation Will Speed Up the Development and Review Time for Your 505(b)(2) Product Breakthrough Therapy Designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. In comparison to Fast Track Designation (discussed in a prior blog), the qualifying criteria for BTD are more […]
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505(b)(2) Nonclinical Development: Examples and Advantages

The 505(b)(2) New Drug Application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant amounts of time, money, and resources. Compared to the 505(b)(1) NDA pathway, which is more standardized and follows the general guidance provided by the International Conference on Harmonization (ICH) M3[1], the nonclinical development program under […]
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