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Latest posts
Last updated about 17 hours ago
Understanding the Risks of Compounded Drugs
about 18 hours ago
Compounded drugs are not FDA-approved. This means the agency does not verify...
Novel Drug Approvals for 2025
about 22 hours ago
Innovative drugs often mean new treatment options for patients and advances in...
About CDER Small Business and Industry Assistance (SBIA)
about 22 hours ago
CDER Small Business and Industry Assistance (SBIA) helps small pharmaceutical business and...
CDER Small Business & Industry Assistance (SBIA)
about 22 hours ago
A Comprehensive Resource for Information on Human Drug Development in Regulation
Recently Issued Guidance Documents
about 23 hours ago
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
1 day ago
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA to Compounders: Know Your Bulks and Excipients Suppliers
1 day ago
FDA has identified several issues over the past few years related to...
Generic Drug User Fee Amendments
1 day ago
This page features news and information for industry and stakeholders about GDUFA...