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Testing must be performed on pharmaceutical products that are submitted to the FDA for approval to demonstrate and ensure that the drug products are effective and ultimately safe for patient use. Stability programs ensure compliance with international regulatory standards and requirements.

This white paper provides an overview of stability testing programs for CDER and CDRH regulatory submissions.

To learn more about stability testing, download the free white paper below.

Differences in Stability Testing for CDER & CDRH includes information on

• CDER Stability Testing Regulations
• CDRH Stability Testing Regulations