The Facet Life Science team has developed significant experience with PET Radiopharm products. Our achievements tell a story of deep domain expertise and practical experience that enables our clients to get to and through the FDA.
- Facet has worked on 6 new drug applications (NDAs) for a variety of diagnostic imaging agents and is actively working on several line extensions for one of these products.
- For these six NDAs and two line extensions, Facet has provided:
- strategic program guidance
- submission leadership
- tactical support
- For one line extension, Facet authored the orphan designation request application which was granted by FDA. For two of these applications, Facet serves as US Agent (FDA’s primary contact about the product).
- Facet authored or reviewed most NDA submission documents for scientific integrity and conformance to FDA requirements. All applications that have been prepared/submitted were in eCTD format and were approved by FDA.
- Two of those products had pre-NDA meetings that were organized and led by Facet staff, one product has two upcoming pre-NDA meetings in which Facet’s nonclinical, clinical, and chemistry experts will be actively involved.
- For all but one of these applications, Facet assisted in the strategic planning of the clinical program to support the NDA application.
- For all NDA applications, Facet was involved in the chemistry, manufacturing, and controls content. Facet also provided pre-approval inspection readiness assessments for two of these clients.
- For one application, Facet prepared a small business waiver which FDA granted (a savings of ~$2M). For another, Facet staff were involved in a Barrier to Innovation waiver.
- Facet has also worked on more than six PET radiopharmaceutical ANDAs and has been involved in the authoring of those applications and all ongoing maintenance (chemistry and labeling supplements, patent updates, new facilities, routine annual maintenance, promotional review committee [advertising and promotions]) to keep those products on the market.
CTA/Link to PET Radiopharm Guidances – this will be under RESOURCES/Learning Links