Article describes inadequate oversight relating to development of COVID-19 vaccines and predating the pandemic
Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of 57 resolved safety signals
Agency has been under heightened scrutiny since the nationwide infant formula shortage and debate over e-cigarette products
To remain on the market, e-cigarette manufacturers must prove there is a public health benefit with their use
Agency has already banned the sale of fruit-flavored e-cigarettes after critics claimed the products targeted teens
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
<p>Possible risks from taking the drug include accidental poisoning and addiction</p>
<p>Concomitant use of central nervous system-depressant drugs listed for 58.4 percent of off-label gabapentin visits</p>
<p>Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol</p>
<p>Major changes to prescribing instructions are rare, especially so soon after approval; change could curb the drug's use</p>