Insights

Understanding the thinking of health authority professionals and a thorough understanding of the US Food and Drug Administration (FDA) regulations and Guidances are critical to developing robust regulatory strategies and registration dossiers. Health authorities evaluating the new drug applications (NDAs) and/or biologic licensing applications (BLAs) generally expect that the sponsors have followed all applicable regulations and Guidances. With the ever evolving regulatory landscape, keeping on top of the updated regulations and Guidances can be a challenge for even the most seasoned regulatory professionals.