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Grace Moser

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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

PBM Integration: Economists Outline Benefits Of Mergers In Senate Hearing

Recent mergers between PBMs and insurers should address one long-term strategic objective of pharma – the recognition by payors of the value of biopharmaceutical products in relation to other medical costs.

Pharmacy Benefit Management M & A

US Medicare And Opioids: Inspector General Sees Improvement

HHS is slowly changing its rhetoric on the use of prescription opioids – edging away from crisis to finding positive trends. A new OIG report on opioid use in Medicare Part D emphasizes sustained positive trends in naloxone rescue and medication assisted treatment alternatives to opioid use disorder.

Neurology Medicare

Hemophilia Accelerated Approval: Factor Activity Useful Surrogate, Panel Says

Variability in assays is important issue in managing patients at “trough” levels, experts at US FDA hemophilia workshop suggest. However, assuming some significant level of activity is restored, the exact level isn’t overly important. 
Blood & Coagulation Disorders Drug Approval Standards

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease In Feedback Meeting

Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes. 
Neurology Research & Development
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