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The firm also didn’t document, on either return goods authorization forms or verbal complaint forms, if it evaluated the complaint to see if it should be reported to the FDA as part of medical device reporting. Read More
The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates. Read More
FDA Commissioner Scott Gottlieb released a letter that tried to raise his staff’s morale, noting that “it’s in times of challenge and uncertainty that the public needs us most.” Read More
“We are pleased to have reached this settlement and will continue to defend our innovative medicines against any challenge,” said Neos CEO Jerry McLaughlin. Read More
PMRS claims that the FDA’s repeated approval of opioids for chronic pain with insufficient evidence of efficacy is a major driving factor behind the ongoing opioid crisis. Read More