Generation Patient comments on the draft PDUFA VIII commitment letter

Written By Sneha Dave
Generation Patient comments on the PDUFA VIII draft commitment letter

Every five years, the Food and Drug Administration (FDA) negotiates an agreement with the pharmaceutical industry over the fees companies pay to have their drug applications reviewed and the performance goals the agency promises in return. Those terms are set out in a commitment letter under the Prescription Drug User Fee Act (PDUFA), and Congress relies on that agreement when it reauthorizes the program. In August 2026, the FDA published its draft commitment letter for PDUFA VIII, held a public meeting on September 16, 2026, and invited stakeholders to file comments under docket FDA-2026-N-8163.

Download the Generation Patient comments on the PDUFA VIII draft commitment letter

Generation Patient filed comments under docket FDA-2026-N-8163 on October 16, 2026. Read the Generation Patient comments on the PDUFA VIII draft commitment letter below.

October 16, 2026

Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA-2026-N-8163 for “Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments.”

Generation Patient is an organization created by and for young adult patients living with chronic and rare medical conditions such as lupus, inflammatory bowel disease, Lyme disease, tuberous sclerosis, and rheumatoid arthritis. We seek to ensure a better future for our generation of patients by providing direct support through peer support groups while driving systems-level change through policy work, leadership programming, and advocacy initiatives. Through our direct support work, we have led over 650 peer support meetings and continue to build the evidence base to build holistic support for young adults with chronic and rare conditions. Generation Patient also refuses to accept any funding from the pharmaceutical, insurance, pharmacy benefit manager, or related health care industries, allowing us to authentically advocate for the needs of our community.

Generation Patient asks FDA to make the following commitments in the final PDUFA VIII commitment letter:

  1. Adopt standardized adult age brackets (18–29, 30–39, 40–49, 50–59, 60–64, 65–74, 75–85, and over 85) in FDA’s public reporting, including action packages, FDA’s Adverse Event Monitoring System (AEMS), and Sentinel.
  2. Use user fee funding to expand the Office of Prescription Drug Promotion’s oversight and enforcement of drug promotion on social media.
  3. Publish an annual list of approvals that relied on a novel surrogate endpoint, and require confirmatory trials that measure clinical outcomes for those approvals, whether accelerated or traditional.
  4. Commit that real-world evidence alone will not substitute for randomized controlled trials to confirm clinical benefit.
  5. Publicly post every postmarketing requirement (PMR) release request and FDA decision, and grant no release while an accelerated approval confirmatory trial is overdue.
  6. Publish complete minutes of industry negotiations, respond in writing to public comments, and give independent patient organizations the consultation rights the draft letter gives industry.

1Disaggregate Data by Adult Age Bracket

Generation Patient urges FDA to commit to standardized adult age brackets (18 through 29 years; 30 through 39 years; 40 through 49 years; 50 through 59 years; 60 through 64 years; 65 through 74 years; 75 through 85 years; and over 85 years) across FDA’s public pre-market and post-market data reporting, including action packages, AEMS, and Sentinel.

FDA’s public reporting aggregates young adults into a single broad adult age group, in both clinical trial data and safety surveillance. For example, in the FDA drug trials snapshot for Alyftrek, a cystic fibrosis therapy, data for young adults are aggregated within the broad 18–65 year age category.1 In the FDA drug trials snapshot for Mounjaro, young adults are likewise aggregated within a single 18–64 year age group.2 FDA’s adverse event reporting has the same problem. For example, in AEMS drug and biologic adverse reactions impacting adults are grouped in only three age brackets: 18–64, 65–85, and more than 85 years.3 These broad groupings make it difficult for patients, clinicians, and researchers using FDA’s public data to detect safety signals affecting young adults and other adult age groups. Yet across all 54 pages of the draft commitment letter, none of the words “age,” “young adult,” “demographic,” or “subgroup” appears.4

Advancing age has pharmacokinetic implications, including changes in drug absorption, distribution, metabolism, and excretion.5 Age also affects immune response, since the thymus, which generates self-tolerant and immunocompetent T cells, shrinks by about 3% each year until middle age and by less than 1% each year after.6 A WHO discussion paper notes that disease incidence, prevalence, and mortality are strongly age-dependent and that “for many purposes, age-specific comparisons may be the most useful.”7 A 2026 peer-reviewed publication, with expertise from clinicians, reached the same conclusion, recommending that safety and efficacy data be disaggregated within finer age brackets rather than reporting 18 through 64 as a single age group.8

Generation Patient asks FDA to revise the commitment letter to ensure that data on young adults and other adult age subgroups are reported in pre-market and post-market reviews and surveillance. We ask that FDA adopt a standardized approach to public adult age data reporting, grouping data using the following brackets: 18 through 29 years; 30 through 39 years; 40 through 49 years; 50 through 59 years; 60 through 64 years; 65 through 74 years; 75 through 85 years; and over 85 years. FDA should incorporate these adult age brackets in the action packages assembled for each approval. Action packages should include a publicly accessible plain-language summary that details the approved use, a description of the populations studied, any differences in safety and efficacy signals, and the number and percentage of trial participants in each adult age bracket. The public meeting on communicating the use of regulatory science tools that FDA has committed to hold by the end of FY 2028 (Section I.L.7) should include age-subgroup reporting on its agenda, and the summary report that follows should address it.9 For post-market surveillance activities, FDA should incorporate these adult age brackets within AEMS to ensure that adverse events affecting specific adult age subgroups are identified. Sentinel 3.0 commitments in Section I.M.2 should include specific language regarding age-stratified signal detection, utilizing these adult age brackets with its deliverables.10

2Strengthen Oversight of Drug Promotion on Social Media

Generation Patient asks FDA to use user fee funding to expand the Office of Prescription Drug Promotion’s (OPDP) monitoring of pharmaceutical promotion on social media.

Prescription drug and compounded drug promotions have increasingly shifted into social media and FDA must ensure its oversight of deceptive advertising is keeping up with the modern communication landscape. We were encouraged by FDA’s September 2025 actions, including sending thousands of letters warning companies to remove deceptive advertising, including on social media, and issuing approximately 100 cease-and-desist letters to companies engaging in a broad range of deceptive promotional activities.11 We also support the inclusion of compounded drug promotions in FDA’s fiscal year 2027 budget justification to Congress, including the proposal to “update the FD&C Act” to clarify FDA’s ability to enforce false or misleading promotions of these products.12 However, the request includes no resources specific to social-media oversight,13 nor does the draft commitment letter mention such resources.14 FDA should have the appropriate resources to increase oversight and enforcement of deceptive pharmaceutical advertising on social media to ensure patients are receiving accurate information about their treatment options.

FDA must do more to protect youth and young adult patients from deceptive pharmaceutical communications. We ask FDA to utilize user fee funding to expand OPDP oversight and enforcement of prescription drug advertising on social media. OPDP should work with social media platforms to identify paid drug promotion, including undisclosed influencer posts, and expand its use of automated tools to find promotions that violate FDA’s rules. OPDP should identify social media promotions that sponsors never submitted on Form FDA 2253, or that differ from what they submitted. Finally, FDA should exercise robust enforcement authority under 21 U.S.C. §§ 331–334 against social media promotions that misbrand drugs under 21 U.S.C. § 352(a) or (n).

3Confirm the Benefit of Drugs Approved on Novel Surrogate Endpoints

Generation Patient asks FDA to publish an annual public list of each approval that relied on a surrogate endpoint never previously used as the primary basis for approval in that context of use, including endpoints developed through the Rare Disease Endpoint Advancement (RDEA) program, with the evidence supporting each endpoint, the status of any confirmatory trial, and efficacy results by adult age bracket. Confirmatory trial requirements should apply to each approval resting on a novel surrogate endpoint, whether accelerated or traditional. FDA should also enforce confirmatory trial deadlines, withdraw indications when clinical benefit is not confirmed, and require labeling that discloses each product’s approval pathway, endpoint basis, and confirmatory trial status.

Speed of approval should not outweigh the collection of robust safety and efficacy data. The draft commitment letter carries forward two PDUFA VII programs that invite sponsors to propose endpoints never previously used as the primary basis for approval, but it adds no commitment to confirm that those endpoints predict a clinical benefit or to report to patients and providers on how they perform.

First, the draft letter continues the early consultation program for sponsors who intend “to use a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use,” and it continues to contemplate such endpoints as a basis for “accelerated or traditional approval.”15 Second, the letter continues the Rare Disease Endpoint Advancement (RDEA) program, including the possibility of accepting a “development program for a common disease that includes innovative or novel endpoint elements, including the specific endpoint and/or the methodology being developed, if there is sufficient justification that the proposal could be applicable to a rare disease.”16 Neither program is accompanied by any commitment to confirm clinical benefit, to report publicly which approvals rested on these endpoints, or to examine whether the endpoints perform consistently across adult age groups.

A 2024 systematic evaluation of the surrogate markers FDA lists as acceptable for non-oncologic chronic diseases found that for most of them, published meta-analyses either did not exist or did not demonstrate a strong association with clinical outcomes.17 The HHS Office of Inspector General reported in January 2025 that for two accelerated approvals (aducanumab and eteplirsen) FDA evaluated analyses that were not part of the sponsors’ original analysis plans, and that eteplirsen’s confirmatory trial had yet to provide evidence of clinical effectiveness eight years after approval.18 Young adults, who may take a newly approved medication for decades, bear the longest exposure to the safety risks and financial cost of a drug approved on an endpoint that later proves not to predict a clinical benefit.

Generation Patient asks FDA to pair these programs with accountability commitments in the final letter. First, FDA should publish, and update annually, a list of each approval that relied on a surrogate endpoint never previously used as the primary basis for approval in that context of use. The publicly accessible list should include a summary of the evidence that the endpoint predicts a clinical outcome,19 the status of any confirmatory study, and efficacy results stratified by the adult age brackets addressed in Section I of this written comment. Second, FDA should require a postmarket confirmatory trial confirming the clinical benefit for each approval that rests on a novel surrogate endpoint, whether the drug was granted accelerated or traditional approval. Third, confirmatory trials should measure clinical outcomes that matter to patients, rather than another surrogate marker.20 Fourth, FDA should engage in robust enforcement: ensuring that confirmatory trials are completed by their planned completion dates, publicly reporting delays, and promptly withdrawing an indication when a confirmatory trial fails to be completed or verify a clinical benefit. Finally, it is important to acknowledge that patients often do not know that a medication was approved on a surrogate endpoint; only half of surveyed physicians reported “usually” telling patients when products were approved based on surrogate measures.21 FDA should commit to transparent labeling, including the product’s approval pathway, endpoint basis, and confirmatory-trial completion status.

4Keep Real-World Evidence from Replacing Randomized Trials

Generation Patient asks FDA to commit that real-world evidence alone will not replace randomized controlled trials for confirming clinical benefit. User-fee-funded Sentinel 3.0 expansions should go towards robust post-market surveillance activities, including age-specific signal detection across adult age subgroups.

In the draft commitment letter, FDA states that, in accordance with section 3022 of the 21st Century Cures Act, it “remains dedicated to advancing the use of RWE to support new intended labeling claims, including the approval of new indications, populations, or dosing information, or to support or satisfy post-approval study requirements.”22 In the Sentinel section, FDA states that these efforts will help enable it to “advance the use of real-world evidence in evaluating drug and biologic safety and effectiveness.”23 Nothing in the letter commits FDA to publish the criteria it will apply when deciding whether real-world evidence can substitute for a randomized controlled trial. FDA increasingly requires or requests real-world evidence studies after approval, yet only 7 of the 208 such studies for 2016–2024 approvals had been fulfilled or submitted as of May 2025,24 and none of the 50 postapproval confirmatory trials could feasibly be emulated with currently available real-world data.25

Generation Patient asks FDA to commit in the final letter that real-world evidence alone will not substitute for randomized controlled trials to confirm clinical benefit. We ask that efforts to expand the Sentinel 3.0 program using user fees be directed towards post-market surveillance activities in order to uncover new safety signals for previously approved drugs, including a public, centralized database of the safety concerns FDA assesses through Sentinel and whether Sentinel was found sufficient to address them.26 Sentinel 3.0 should also be expanded in order to identify adult age specific safety signals across adult age subgroups.

5Safeguard Postmarketing Requirements

Generation Patient asks FDA to publicly post every PMR release request and every agreement or non-agreement letter, with its rationale, in the postmarketing requirements database. FDA should also commit that no PMR for an accelerated approval will be released while its confirmatory trial is past its original completion date.

Postmarketing requirements are a pivotal tool FDA has to resolve questions that remain open at approval, including safety studies and trials required under section 505(o)(3) and confirmatory trials required to verify clinical benefit for drugs granted accelerated approval under section 506(c). For young adult patients facing decades of treatment, safeguarding the completion of these requirements turns provisional evidence on the safety and efficacy of a medication into reliable evidence.

The draft commitment letter carries forward from PDUFA VII a sponsor-initiated process for requesting release from an existing PMR.27 Under the “post-approval review of existing PMRs” provision, a sponsor submits “a request summarizing their rationale for why an existing PMR is no longer needed,” FDA will respond within 60 days with an agreement or non-agreement letter, and a sponsor that receives a non-agreement letter may request reconsideration, with a written response due by FDA within 45 days.28 This process is one-directional: giving sponsors a defined path, with defined timelines for FDA, and the opportunity to appeal when they seek to eliminate their post-market requirements. Nothing in the process gives the public notice that a request has been made or an opportunity to comment.

Generation Patient asks FDA to add two safeguards to the “post-approval review of existing PMRs” process in the final commitment letter. First, FDA should post every release request and every agreement or non-agreement letter, with its rationale, on the public Postmarket Requirements and Commitments database. Second, FDA should commit that no release will be granted for a PMR tied to an accelerated approval while the associated confirmatory trial is past its original planned completion date.

6Increase Patient Participation in PDUFA Reauthorization

Generation Patient asks FDA to publish complete minutes of its negotiations with industry and to respond in writing to public comments before sending the agreement to Congress. FDA should also grant patient, consumer, and public health organizations, especially those independent of industry funding, the same recurring consultation rights the draft letter provides industry.

Generation Patient has participated in every one of the PDUFA VIII stakeholder engagements required under section 736B(f) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 379h-2(f), including the initial public meeting under paragraph (f)(2) and the monthly meetings with patient and consumer advocacy groups under paragraph (f)(3). However, the negotiations concerning key aspects of the user fee levels and performance commitments occurred between FDA and industry, with industry-independent patient and public health organizations excluded from those conversations. Nowhere in section 736B(f) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 379h-2(f), did Congress explicitly state that “representatives of patient and consumer advocacy groups” are barred from participation in negotiations with the “regulated industry” or prevented from receiving complete minutes of negotiations. In addition, many PDUFA proposals offered during the stakeholder meetings were met with FDA’s position that PDUFA reauthorization “focuses on enhancements to the drug review process, not FDA policy,”29 yet the draft commitment letter contains many new policy proposals that benefit the interests of industry, not patients. Across all 54 pages of the draft commitment letter, patient groups appear mainly as audiences for outreach and engagement, while only the regulated industry is given a role in jointly planning implementation meetings, such as the biannual Sentinel updates.30

Generation Patient reiterates the transparency requests in its 2025 comment and asks that they apply to future PDUFA reauthorizations.31 We also ask FDA to:

  1. Publish complete minutes of negotiation meetings with industry that go beyond the summaries section 736B(f)(7) requires.
  2. Respond in writing to public comments on the draft commitment letter before transmitting the agreement to Congress, identifying which recommendations were adopted and which were not.
  3. Expand to patient, consumer, and public health organizations the recurring consultation rights the draft letter grants industry, especially for industry-independent organizations, including an equal role in planning and setting the agenda in the biannual Sentinel 3.0 meetings in Section I.M.2.

FDA’s mission is to protect our nation’s public health, including by ensuring the safety, efficacy, and security of human drugs and biological products.32 The draft commitment letter does not fulfill this mission in its current form. Generation Patient looks forward to continued collaboration to ensure that the final commitment letter allows FDA to achieve its mission and that young adult patients can access safe and effective medications.

Sincerely,

Luis Gil Abinader
Policy Director
Generation Patient
luis@generationpatient.org

Alexander Naum
Policy Manager
Generation Patient

Notes

  1. U.S. Food & Drug Admin., Drug Trials Snapshot: ALYFTREK (updated June 25, 2025), https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshot-alyftrek (last visited Sept. 11, 2026). ↩
  2. U.S. Food & Drug Admin., Drug Trials Snapshot: MOUNJARO (updated June 13, 2023), https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-mounjaro (last visited Sept. 11, 2026). ↩
  3. U.S. Food & Drug Admin., Reports Received by Age Group, FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Drugs and Biologics, https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis (last visited Sept. 11, 2026); see also Shaheen E. Lakhan, Early Evaluation of the Food and Drug Administration (FDA) Adverse Event Monitoring System (AEMS): An Analysis of Over 32 Million Pharmacovigilance Reports, 18 Cureus e106259, tbl. 3 (2026), https://doi.org/10.7759/cureus.106259 (reporting that 38.5% of AEMS reports do not specify age). ↩
  4. U.S. Food & Drug Admin., PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2028 Through 2032 (Aug. 14, 2026), https://www.fda.gov/media/193977/download [hereinafter Draft PDUFA VIII Commitment Letter]. ↩
  5. A.A. Mangoni & S.H.D. Jackson, Age-Related Changes in Pharmacokinetics and Pharmacodynamics: Basic Principles and Practical Applications, 57 Brit. J. Clinical Pharmacology 6, 6 (2004), https://doi.org/10.1046/j.1365-2125.2003.02007.x. ↩
  6. Zhanfeng Liang et al., Age-Related Thymic Involution: Mechanisms and Functional Impact, 21 Aging Cell e13671, § 2.1 (2022), https://doi.org/10.1111/acel.13671. ↩
  7. O.B. Ahmad et al., Age Standardization of Rates: A New WHO Standard 3 (World Health Org., GPE Discussion Paper Series No. 31, 2001), https://cdn.who.int/media/docs/default-source/gho-documents/global-health-estimates/gpe_discussion_paper_series_paper31_2001_age_standardization_rates.pdf. ↩
  8. Rose Eleanor Keller, Sneha Dave & Katherine Melton, Young Adults in Clinical Trials: A Roundtable Proceedings, 18 Open Access J. Clinical Trials 1 (2026), https://doi.org/10.2147/OAJCT.S616460. ↩
  9. Draft PDUFA VIII Commitment Letter, supra note 4, at 36 (Section I.L.7). ↩
  10. Id. at 37–38 (Section I.M.2). ↩
  11. Press Release, U.S. Food & Drug Admin., FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising; Letter from Martin A. Makary, Comm’r of Food & Drugs, U.S. Food & Drug Admin., to Pharmaceutical Company Application Holders (Sept. 9, 2025), https://www.fda.gov/media/188616/download?attachment. ↩
  12. U.S. Food & Drug Admin., Fiscal Year 2027 Justification of Estimates for Appropriations Committees 16 (2026), https://www.fda.gov/media/191778/download. ↩
  13. Id. ↩
  14. Draft PDUFA VIII Commitment Letter, supra note 4. ↩
  15. Compare Draft PDUFA VIII Commitment Letter, supra note 4, at 26 (Section I.L.2), with U.S. Food & Drug Admin., PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, at 29 (Section I.K.3), https://www.fda.gov/media/151712/download [hereinafter PDUFA VII Commitment Letter] (identical language). ↩
  16. Compare Draft PDUFA VIII Commitment Letter, supra note 4, at 28–29 (Section I.L.3.a), with PDUFA VII Commitment Letter, supra note 15, at 31 (identical common disease language). ↩
  17. Joshua D. Wallach et al., Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments, 331 JAMA 1646 (2024), https://doi.org/10.1001/jama.2024.4175. ↩
  18. Off. of Inspector Gen., U.S. Dep’t of Health & Hum. Servs., OEI-01-21-00400, How FDA Used Its Accelerated Approval Pathway Raised Concerns in 3 of 24 Drugs Reviewed 9, 16 (Jan. 2025), https://oig.hhs.gov/documents/evaluation/10160/OEI-01-21-00400.pdf. ↩
  19. Wallach et al., Associations Between Surrogate Markers, supra note 17 (suggesting that FDA “could publicly report and routinely update an accompanying summary of evidence supporting” surrogacy). ↩
  20. See Joshua D. Wallach et al., Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009–2018, 4 JAMA Network Open e2133601, tbl. 2 (2021), https://doi.org/10.1001/jamanetworkopen.2021.33601 (finding that 19 of 32 indications had postapproval trials with surrogate primary endpoints). ↩
  21. Sanket S. Dhruva et al., Physician-Patient Communication About Novel Drugs and High-Risk Medical Devices, 45 Med. Decision Making 156 (2025), https://doi.org/10.1177/0272989X241302096. ↩
  22. Draft PDUFA VIII Commitment Letter, supra note 4, at 35 (Section I.L.5.g). ↩
  23. Id. at 38 (Section I.M.2). ↩
  24. Louis Y. Li et al., Premarket and Postmarket Real-World Evidence Studies Supporting U.S. Food and Drug Administration Regulatory Decision-Making, 2016–2024, 23 Clinical Trials 363 (2026), https://doi.org/10.1177/17407745251415190 (finding also that 197 of the 208 postmarket studies were designed to provide evidence on safety alone). ↩
  25. See Joshua D. Wallach et al., Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 4 JAMA Network Open e2133667 (2021), https://doi.org/10.1001/jamanetworkopen.2021.33667; but see Jessica M. Franklin et al., Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative, 143 Circulation 1002 (2021), https://doi.org/10.1161/CIRCULATIONAHA.120.051718 (finding equivalent regulatory conclusions in 6 of 10 emulated trials). ↩
  26. Erfan Taherifard et al., US Food and Drug Administration Sentinel Initiative and Postmarket Drug Safety Surveillance: A Review, 7 JAMA Health Forum e260754 (2026), https://doi.org/10.1001/jamahealthforum.2026.0754 (recommending “a publicly available, centralized, and regularly updated database of safety concerns”). ↩
  27. Compare Draft PDUFA VIII Commitment Letter, supra note 4, at 13–14 (Section I.D.2), with PDUFA VII Commitment Letter, supra note 15, at 13–14 (Section I.C.2) (establishing the same process with the same timelines). ↩
  28. Draft PDUFA VIII Commitment Letter, supra note 4, at 13–14 (Section I.D.2). ↩
  29. U.S. Food & Drug Admin., Prescription Drug User Fee Act (PDUFA) Reauthorization Stakeholder Meeting with FDA: Meeting Summary 1 (Nov. 7, 2025), https://www.fda.gov/media/189874/download. ↩
  30. See Draft PDUFA VIII Commitment Letter, supra note 4, at 38 (Section I.M.2.b) (“FDA will jointly plan and conduct meetings with the regulated industry on the plans and progress for Sentinel 3.0”), 49 (Section IV.A.1.a) (quarterly IT meetings that “FDA and the regulated industry will jointly plan and conduct”). ↩
  31. See Generation Patient, Comment Letter on Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments (Aug. 15, 2025) (Docket No. FDA-2025-N-0816, Comment ID FDA-2025-N-0816-0057), https://www.regulations.gov/comment/FDA-2025-N-0816-0057. ↩
  32. U.S. Food & Drug Admin., What We Do (Nov. 21, 2023), https://www.fda.gov/about-fda/what-we-do. ↩
Sneha Dave
Next

Sponsored Influencer Database