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Patent Certifications and Suitability Petitions
Information on patents and suitability petitions that impact the availability of generic drugs.GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
FEI Number 3032144832
Firm Name GenoGenix, LLC
Record Type 483
State FL
Establishment Type Outsourcing FacilityC3TI Areas of Interest
C3TI’s areas of interest span drug development programs, therapeutic areas, and disciplines. Learn more.Drug Alerts and Statements
FDA Drug Alerts and StatementsPure Indulgence Aesthetics – 12/12/2025
Pure Indulgence Aesthetics – 12/12/2025. Country: United States. Record Type: 483Complex Innovative Trial Design Meeting Program
As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs, as highlighted in the sixth iteration o
