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If the FDA follows the panel's advice, as it usually does, the makers of ECT devices may need to provide the agency with additional safety and efficacy evidence, like that required for prescription drugs.
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As a result, many doctors have been using a modified dose of Avastin instead of Lucentis, assuming even asserting that it achieved equally good results with no additional safety risks.
FORBES: Patient Safety and 'Off-Label' Drug Use
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To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
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In a brief statement, however, Shire says that recent meetings with the FDA indicated additional controlled trials will be required for approval, although safety was not an issue.
FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost
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"The health and safety of AAM's employees will remain of paramount importance in this difficult time with additional workplace support being given to employees to help them seek alternative employment, " he said.
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