Privigen

by Pill Pals Customer Service | Jun 18, 2025 | News

STN: 125201Proper Name: Immune Globulin Intravenous (Human), 10% LiquidTradename: PRIVIGENManufacturer: CSL Behring AGIndication:For the treatment of:Primary humoral immunodeficiency (PI)Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and...

Clinical Outcome Assessments (COA) Qualification Program Submissions

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

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment of...

Clinical Outcome Assessments (COA) Qualification Program

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

COAQP Email UpdatesSubscribe for COAQP emails. Receive timely communications such as procedural changes, newly qualified COAs and other COAQP related announcements.COAQP Stages and Submissions Content current as of: 11/09/2021 Regulated Product(s) Topic(s)...

Resources for Biomarker Requestors

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

How to engage with the Biomarker Qualification Program (BQP)If you have pre-submission or general inquiry questions or you want to make a meeting request, please contact BQP at: CDER-BiomarkerQualificationProgram@fda.hhs.govQualification ProcessBiomarker qualification...

FDA’s ISTAND Pilot Program accepts submission of first artificial inte

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

[1/23/2024] FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This...

Q’Apel Removes Hippo 072 Aspiration System with Cheetah Delivery Tool

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

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductsProduct Names: 072 Aspiration System...

Qualified Clinical Outcome Assessments (COA)

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

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of...

Blood Products Administration Set Recall from Fresenius Kabi

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

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected Product Product DescriptionPart...

COA Qualification Prog FAQs

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

Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program InformationCOA Qualification Considerations and RequirementsCOA Development and...