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 ...
A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license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 "Analytical Method Validation, Verification and Transfer Virtual Seminar (Jan 14th - Jan 15th, 2026)" training has been added to ResearchAndMarkets.com's offering. Dependable analytical results ...
Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.
Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results