Comment from Sonia Vallabh

Summary: Sonia Vallabh, an investigator at the Broad Institute of MIT and Harvard, supports the draft guidance but urges the FDA to broaden the definition of "individualized therapies" to include drugs targeting underlying genetic causes rather than just single-patient mutations. She also suggests using more inclusive terminology like "oligonucleotide," clarifying the distinction between "genetically targeted" and "individualized" therapies, and strengthening language regarding data sharing for rare diseases.