7/102 sources · 2 publishersUpdated Oct 8, 21:03 UTC
FDA enrolls RaniPill platform in emerging technology program
Rani Therapeutics said the FDA enrolled its RaniPill Capsule platform in the agency's Emerging Technology Program. The designation gives the company an early channel to discuss manufacturing, technical and regulatory matters with FDA staff, including before formal submissions and possible facility visits.
Why it matters
Rani said the FDA interaction should support automation of its integrated manufacturing operations as it prepares for wider clinical use. The discussions can apply across the platform instead of being confined to one drug candidate.
Key facts
- 1The FDA added Rani Therapeutics' RaniPill Capsule platform to its Emerging Technology Program. globenewswire.com
- 2The program is run by the FDA's Center for Drug Evaluation and Research. globenewswire.com
- 3Rani can hold pre-submission discussions with the FDA Emerging Technology Team and may receive site visits through the program. globenewswire.com
- 4Rani said its partnerships with Chugai, ProGen and PegBio cover rare disease, immunology and obesity. globenewswire.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.