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Last updated 1 day ago
M11 Clinical Electronic Structured Harmonised Protocol
1 day ago
M11 Clinical Electronic Structured Harmonised Protocol
First Generic Drug Approvals
1 day ago
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a...
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
1 day ago
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
President's Emergency Plan for AIDS Relief (PEPFAR)
1 day ago
Presidential Emergency Plan for AIDS Relief content
GDUFA Paid Facilities List
2 days ago
This list contains GDUFA facility payments received by the Agency. Data are...
Human Drug Compounding Outsourcing Facility Fees
2 days ago
Human Drug Compounding Outsourcing Facility Fees
Prescription-to-Nonprescription (Rx-to-OTC) Switches
2 days ago
A sponsor of a nonprescription drug product may seek to market a...
Drug Application Process for Nonprescription Drugs
2 days ago
There are two regulatory pathways to bring a nonprescription drug to market...
CSL Behring - 716297 - 09/09/2025
3 days ago
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