2021 Statements & Letters

Read and download our letters and comments.

CMS

Inpatient Prospective Payment System

Congress

Medicaid Coverage for DNA Sequencing

Value Based Purchasing Proposed Rule

21st Century Cures 2.0

21st Century Cures 2.0 [Introduced]

FDA

Gene Therapy for Neurodegenerative Disease Guidance

Nonclinical Biodistribtuion Considerations for Gene Therapy Products Guidance; International Council for Harmonisation

Prescription Drug User Fee Act Reauthorization

IND Submissions for Individualized ASO Products Guidance

Studying Multiple Versions of a CGT Product in an Early-Stage Trial Guidance

Miscellaneous

Newborn Screening Saves Lives Act

Facilitating the Early Diagnosis and Equitable Delivery of Gene-Targeted Therapies

Medicaid Patient Access to Gene Therapy

Draft Strategic Plan 2021-2026

Multiple Myelome Draft Evidence Report