Stakeholders widely criticize FDA estimates for the industry’s NDI costs – 20 hours to prepare a notification and no capital costs. Industry reps argue the agency’s evolving approach to NDIs will increase costs, and the two sides disagree over the role and cost of research.
Stakeholders say FDA steeply lowballs costs in its latest estimate for the burden on industry of new dietary ingredient notifications, further underscoring the gap between agency and industry over NDI issues.
The agency estimates a firm needs 20 hours to prepare an NDI notification and says no capital costs are associated...
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
