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Latest posts
Last updated about 9 hours ago
FDA Roundup: April 26, 2024
about 14 hours ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
Important Addresses for Regulatory Submissions
about 14 hours ago
Important Addresses for Regulatory Submissions
Drug Application Process for Nonprescription Drugs
about 15 hours ago
There are two regulatory pathways to bring a nonprescription drug to market...
Therapeutic Biologics Applications (BLA)
about 15 hours ago
Therapeutic Biologics Applications (BLA)
How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
about 15 hours ago
How physicians interpret information about prescription drugs in scientific publications vs. promotional...
2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/06/2024
about 17 hours ago
The Food and Drug Administration (FDA or the Agency) is announcing its...
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
about 20 hours ago
Content and Format of Composition Statement and Corresponding Statement of Ingredients in...
Frequently Asked Questions | Clozapine REMS Modification
about 20 hours ago
The Clozapine REMS is a shared system REMS for all approved clozapine...
A Milestone in Facilitating the Development of Safe and Effective Biosimilars
about 21 hours ago
The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars...
Generic Drug Research Collaboration Opportunities
1 day ago
The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program...
Peptides, proteins, and the risks of cardiac arrythmias: A CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids
1 day ago
Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests...
Combating Antibiotic Resistance
1 day ago
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon...