The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...
The guidance outlines key issues for determining the reliability and relevance of the data and that should be addressed in the study protocol, including: the appropriateness and potential limitations ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback