Aleon News
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)...