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Étiqueté : USA

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FDA issues approval of Encelto

The FDA has approved revakinagene taroretcel-lwey (brand name, Encelto) for the treatment of adults with idiopathic Macular Telangiectasia type 2 (MacTel). It is the first FDA-approved treatment for Macular Telangiectasia type 2, a neurodegenerative retinal disease that...

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FDA – Communications from firms to health care providers (HCPs) regarding scientific information on unapproved uses of approved/cleared medical products: questions and answers guidance for industry

The FDA has issued a final guidance describing the FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to HCPs engaged in prescribing or administering medical products...