Q1 2023 Aleon Regulatory Frontiers Newsletter

February 2023

As a regulatory affairs consulting company, we fully understand that staying informed about regulatory affairs in the pharmaceutical industry can be quite challenging. Our goal with this quarterly newsletter is...

Rare Diseases Remain Underserved, FDA & Aleon Increase Focus on Orphan Drug Designations

January 2023

Rare diseases are defined in the US as diseases or conditions that affect fewer than 200,000 individuals. The relatively small patient population has historically meant therapies are harder to come...

Sponsors Continue to Look to Aleon for Combination Product INDs

December 2022

Aleon Pharma International, Inc. is supporting several Investigational New Drug Applications (INDs) for combination products, including an upcoming submission this year. A combination product is defined in 21 CFR 3.2(e),...

Aleon’s eCTD Team Submits 3 INDs in One Day

November 2022

On November 30th, 2022, our eCTD team faced a worthy challenge as they worked to submit three Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA)...