"Companies filing their first NDA or BLA have a significantly lower likelihood of receiving first-cycle approval. Some factors contributing to this fact were discussed in an independent evaluation of FDA's first-cycle review performance, conducted by Booz Allen and currently being updated. This session, which specifically targets emerging and first-time filer companies, will further explore these factors from the perspective of different industry stakeholders, including representatives from industry and regulatory authorities. Panelists will also discuss best practices and offer recommendations to emerging
companies on how to prepare for and execute against their first product approval application."

Objective1: Share relevant perspectives from Booz Allen's First-Cycle Evaluation and additional studies.

Objective2: Highlight issues facing emerging companies and first-time filers.

Objective3: Provide tools and best practices.