Novo Nordisk Inc. – 716495

by Pill Pals Customer Service | Sep 17, 2025 | News

Recipient: Recipient Name Maziar Mike Doustdar Recipient Title President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill RoadPlainsboro, NJ 08536United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary...

Drug Trials Snapshots: ANDEMBRY

by Pill Pals Customer Service | Sep 16, 2025 | News

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...

CDER and CBER accept first submission to ISTAND Pilot Program

by Pill Pals Customer Service | Sep 16, 2025 | News

[9/7/2022] FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.FDA launched...

Understanding the Risks of Compounded Drugs

by Pill Pals Customer Service | Sep 16, 2025 | News

Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed.Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate...

Compounding and the FDA: Q & A

by Pill Pals Customer Service | Sep 16, 2025 | News

Why do some patients need compounded drugs?A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a...