How to Successfully Respond to an FDA Information Request (IR)
Getting your vaccine or therapeutic approved by the FDA is a significant accomplishment. But...
read DetailsExamines the effectiveness of simulated transport studies. This new study uses a holistic form of methodology testing the different hazards that arise in cold chain transport. In doing so, the “industry standards” of the following areas are questioned and tested.
Getting your vaccine or therapeutic approved by the FDA is a significant accomplishment. But...
read DetailsThis six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...
read DetailsAre you aware of the open data files published online by the FDA? This...
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