Public Comments:

• Comment on FDA-2025-N-6895: Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List (7/21/26)

• Comment on Representative Auchincloss’ Legislative Draft on Next-Generation U.S. Clinical Development to Accelerate Cures (6/30/26)

• Comment on FDA-2026-N-2366: Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments (6/30/26)

• Comment on FDA-2026-N-2476: Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments (6/5/26)

• Comment on FDA-2025-N-4731: Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments (5/08/26) 

• Comment on FDA-2026-D-1256: Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause (4/27/26)

• Comment on CMS-2025-1889: Global Benchmark for Efficient Drug Pricing (2/25/26)

• Comment on CMS-2025-1888: Guarding U.S. Medicare against Rising Drug Costs Model (GUARD) (2/25/26)

Public Comments:

• Comment on FDA-2011-D-0164: Safety Labeling Changes—Implementation of Section 505 (o)(4) of the Federal Food, Drug and Cosmetic Act; Draft Guidance for Industry (11/18/25)

• Comment on FDA-2025-N-1157: Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments (9/04/25) 

• Comment on FDA-2025-N-0816: Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments (8/15/25) 

• Comment on FDA-2024-D-3334: Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Guidance for Industry; Draft Guidance (3/11/25)

• Comment on FDA-2024-D-2033: Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry (3/07/25)

Public Comments:

• Comment on FDA-2021-D-0789: Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Studies (9/27/24)

• Comment on FDA-2017-D-0154: Considerations in Demonstrating Interchangeability With a Reference Product: Update (8/20/24)

• Comment on 2024-11188: National Institutes of Health (NIH) Office of Science Policy: Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity through Access Planning (7/22/24)

• Comment on: Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 (7/02/24)

• Comment on FDA-2016-D-3561: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (4/29/24)

• Comment on FDA-2023-D-4395: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff (2/20/24)

• Comment on NIST-2023-008: Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (2/06/24)

Amicus Briefs:

• US v Gilead Science, Inc et al (12/19/24)

• American Clinical Laboratories Association et al v FDA and Association of Molecular Pathology et al v FDA (11/04/24)

• The Center For Investigative Reporting And Will Evans v Dept of Labor (7/17/24)

Public Comments:

• Comment on FDA-2023-D-2318: Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (12/18/23)

• Comment on FDA-2023-D-3133: Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (12/05/23)

• Comment on FDA-2023-D-3132: Evidentiary Expectations for 510(k) Implant Devices (12/05/23)

• Comment on CMS-2023-0107: Medicare Program; Transitional Coverage for Emerging Technologies (9/13/23)

• Comment on FDA-2023-D-0559: 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, Guidance for Industry (9/11/23)

• Comment on FDA-2023-N-1956: Increasing Patient Access to At-Home Use Medical Technologies (8/29/23)

• Comment on CMS: Coverage with Evidence Development Proposed Guidance Document (8/21/23)

• Comment on FDA-2023-D-0110: Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (5/24/23)

• Comment on FDA-2022-D-2870: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders- Draft Guidance (5/22/23)

Amicus Briefs:

• Relentless v Dept of Commerce (Supreme Court case that may overturn federal agency deference) (12/22/2023)

White Papers:

• Addressing Drug Shortages: Emergent Challenges, Structural Factors, and Potential Policy Reforms (9/11/23)

• Response to RFI on Drug Shortages (7/07/23)