2022 Statements & Letters

Read and download our letters and comments.

CMS

Inpatient Prospective Payment System

Medicare Physician Fee Schedule Proposed Rule 2023

Congress

PDUFA VII Reauthorization

Prevent Pandemics Act Discussion Draft

FY23 Appropriations Omnibus Sign-On Letter

Sign-on Letter to Congressional Staff-SCD Comprehensive Care Act

FDA

ARM-FDA Roundtable on Potency Assays Summary

Real World Data: Assessing Registries to Support Regulatory Decision-Making Guidance

Considerations for the Development of CAR T Products Guidance

Human Gene Therapy Products Incorporating Human Genome Editing Guidance

Diversity Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Trials Guidance

Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance

HHS

Screening Framework for Providers of Synthetic Double-Stranded DNA