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Diagnostic Tests Advisory Opinions

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Biopharmaceutical Company Arrangement to Provide Free Genetic Testing and...

King & Spalding on

Last week, OIG posted Advisory Opinion No. 22-06 regarding a biopharmaceutical company’s (BioPharm Co.) arrangement to provide free genetic testing and genetic counseling services to patients potentially eligible for...more

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