by Pill Pals Customer Service | Jun 18, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Emory University Rollins School of Public Health, Atlanta, Georgia, USA...
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...
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...
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)...
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...
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...
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