A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license applications (BLAs) and ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...