During the current COVID-19 pandemic, it is important to find strategies to keep your drug development program moving forward. With many studies now paused, cancelled completely, or in the early…
Read More
If you missed our live panel discussion on how the drug development industry is being impacted by the COVID-19 pandemic, we have assembled this post to highlight some of the…
Read More
To formally request approval to market a new drug in the United States, sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the…
Read More
A fundamental question for any drug development program is which regulatory pathway to pursue. The answer is important to determine early on, because it dictates the scope of clinical and…
Read More
The Power of Vaccinations Every year, vaccines are administered to millions of people to mitigate the spread of a wide variety of infectious diseases. One of the best known and…
Read More
An active Investigational New Drug (IND) application is required by the U.S. Food and Drug Administration (FDA) before human studies may be conducted. For new drugs and even most follow-on…
Read More
Adaptive clinical trial designs have been used extensively in medical device development, and lessons learned are now being applied to drug development. Adaptive design can reduce the number of patients…
Read More