ARM Comments for FDA-2023-D-2318 for Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
ARM Comments to FDA-2023-D-0559 for Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act
“Independent Third-Party Assessment of Investigational New Drug Food and Drug Administration-Sponsor Communication Practices in Prescription Drug User Fee Act VI;
EMA: Submission of comments on 'Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations'
CMS: HIPPS for FY 2020; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals
HHS: OIG Proposed Rule on the Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
ICER RFI: Evaluation of Potentially Curative Treatments and for Translating the Results of Cost-Effectiveness Analyses into Recommendations for Value-Based Price Benchmarks
NIH: "Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules"
Proposal for a Regulation of the European Parliament and of the Council on Health Technology Assessment and Amending Directive 2011/24/EU (COM(2018) 51 final)
ARM's Response to the House Committee on Education and the Workforce's RFI on ERISA's 50th Anniversary
Letter
March 2024