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Grace Moser

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Advanced Manufacturing May Require US FDA To Think Differently About Guidance

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’

FDA Guidance Documents

Advanced Manufacturing May Require US FDA To Think Differently About Guidance

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’

Manufacturing Guidance Documents

US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data

Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.

Cancer Coronavirus COVID-19

Gene Therapy Payment Models Could Be One Focus For 'Cures II'

House Republicans are eager to keep working on legislation to permit innovative payment models for curative gene and cell therapies. Democrats, for now, are focused on other priorities.

Gene Therapy Reimbursement

Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers

Depending on who you ask, black box warnings can fail to curb inappropriate prescribing or scare off patients who would benefit from an effective therapy. FDA is proposing a provider survey to find out what perceptions really are.

Drug Safety Regulation

Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers

Depending on who you ask, black box warnings can fail to curb inappropriate prescribing or scare off patients who would benefit from an effective therapy. FDA is proposing a provider survey to find out what perceptions really are.

Drug Safety Regulation
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