FACET BY THE NUMBERS
Total submissions to FDA January – March 2023: 41 (on average over 3 submissions a week!)
Early-stage development highlights: preparation/submission of 7 new INDs and submitted over 20 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual reports, safety reporting/DSURs); conducted formal meetings with CBER, CDER, and CDRH; were involved in an Expanded Access program for pediatric patients with a rare disease; prepared several gap analyses and regulatory development plans; helped several organizations obtain orphan designation for their products, ongoing review of public-facing information (e.g., websites, flyers, conference presentations) about investigational products; helped 1 organization find specialty investigational CDMO; and completed 1 CMC vendor qualification
Lage-stage development highlights: preparation of Phase 3 clinical regulatory strategies; active participation in 1 commercial launch; supported removal of 1 drug from drug shortages list; supported 1 organization to secure external funding; supported 1 organization to divest product; helped 1 organization select commercial CDMO; and ongoing ad promo strategy and document review