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- Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Development and licensure of vaccines to prevent COVID-19: guidance for industry1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
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