Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
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- Title
- Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
- Posted
- May 1, 2026
- Comment period
- May 1, 2026 – Jul 1, 2026
- FR Doc
- 2026-08524
- Topics
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Stance breakdown
Who commented
Breakdown by commenter type.
Comments over time
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Support × commenter type
How each type splits across stance.
Issues raised
The docket's canonical issues. Select one to browse its comments.
Position map
Who stands where on each issue?
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Issues shown
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| Organization | Benefits of pfdd meetings | Patient-centered research and advocacy | Lifecycle of patient engagement |
|---|---|---|---|
AbbVie BusinessSupport AbbVie supports the FDA's request for information regarding the impacts of Patient-Focused Drug Development (PFDD) meeti | · | ||
Alexion Pharmaceuticals BusinessSupport Alexion Pharmaceuticals, a division of AstraZeneca focused on rare diseases, supports the use of Patient-Focused Drug De | · | ||
Arthritis Foundation AdvocacySupport The Arthritis Foundation supports the FDA's Request for Information on Patient-Focused Drug Development (PFDD) meetings, | |||
Biotechnology Innovation Organization (BIO) Trade associationSupport The Biotechnology Innovation Organization (BIO) supports the FDA's initiative regarding Patient-Focused Drug Development | · | ||
Canary Advisors BusinessSupport Canary Advisors supports the initiative to establish a public docket and requests that the FDA create a consistent, tran | |||
Critical Path Institute AdvocacySupport The Critical Path Institute (C-Path), a nonprofit organization, supports the FDA's initiative on patient-focused drug de | · | · | |
CurePSP AdvocacySupport CurePSP, a non-profit organization for atypical parkinsonian diseases, supports the Patient-Focused Drug Development (PF | |||
Faegre Drinker Consulting BusinessSupport Faegre Drinker Consulting, a consulting firm that assists patient advocacy organizations, supports the FDA's Patient-Foc | |||
Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF) AdvocacySupport The Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF) support the FDA's in | · | ||
Hepatitis B Foundation AdvocacySupport The Hepatitis B Foundation supports the FDA's patient-focused drug development (PFDD) program, highlighting how it has t | · | ||
Huntington's Disease Society of America AdvocacySupport The Huntington's Disease Society of America (HDSA) supports the FDA's Patient-Focused Drug Development (PFDD) meetings a | |||
International Pemphigus and Pemphigoid Foundation (IPPF) AdvocacySupport The International Pemphigus and Pemphigoid Foundation (IPPF) supports the proposed action by highlighting the positive i | |||
Lupus and Allied Diseases Association, Inc. AdvocacySupport The Lupus and Allied Diseases Association, Inc. | · | ||
Lupus Foundation of America AdvocacySupport The Lupus Foundation of America supports the FDA's initiative to document the impacts of Patient-Focused Drug Developmen | |||
Muscular Dystrophy Association AdvocacySupport The Muscular Dystrophy Association (MDA) expresses strong support for the FDA's Patient-Focused Drug Development (PFDD) | |||
National Eczema Association AdvocacySupport The National Eczema Association (NEA) supports the FDA's request for information on Patient-Focused Drug Development (PF | · | · | |
National Health Council (NHC) AdvocacySupport The National Health Council (NHC) supports the FDA's request for information on the impacts of Patient-Focused Drug Deve | · | ||
National Organization for Rare Disorders (NORD) AdvocacySupport The National Organization for Rare Disorders (NORD) supports the Patient-Focused Drug Development (PFDD) program and adv | |||
UCB, Inc. BusinessSupport UCB, Inc., a global biopharmaceutical company, supports the FDA's efforts to incorporate patient voices into drug develo | · | · | |
United Liver: Leaders In Liver AdvocacySupport United Liver, an international nonprofit consortium representing patients with liver diseases, supports the Patient-Focu |
1 organization-typed comment could not be identified.
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
- Jun 29, 2026Comment from Clinical Outcomes SolutionsSupportBusiness📎 Attachment
Clinical Outcomes Solutions (COS) supports the use of Patient Focused Drug Development (PFDD) meetings but argues that the FDA should improve how findings from these meetings are translated into regulatory-grade qualitative evidence. They propose specific steps to standardize data collection, analysis, and reporting to better support clinical development programs.
Read comment → - May 2, 2026Comment from Berger MitchellSupportIndividual📎 Attachment
Mitchell Berger, commenting in a personal capacity, supports the FDA's Patient-Focused Drug Development (PFDD) meetings and suggests several improvements to the program. He recommends that the FDA commit staff to attend both FDA-led and externally-led meetings, standardize expectations and templates for external meetings, provide a list of suggested meeting topics to address unmet needs, and enhance collaboration with other government agencies and the Center for Devices and Radiological Health.
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