Jill Wechsler is ACT's Washington Correspondent

Jill Wechsler, ACT's Washington Correspondent

FDA is at a “pivotal moment” for the nation’s public health and for global well-being due to the potential for realizing important gains in medical treatment based on science, Commissioner Robert Califf, MD, told the Washington legal and regulatory community last week at the annual meeting of the Food and Drug Law Institute (FDLI). He aims to address these challenges by improving FDA supply chain management in all areas, with digitally integrated systems that support preemptive actions and permit swift reaction to product shortages. Another priority is to counter widespread misinformation about vaccines and medical products through an emphasis on science-based decision-making at the agency and to advance medical product development based on appropriate communication between agency experts and those in regulated industry.

Califf emphasized the importance of improved information and data management systems in all FDA operations to support agency oversight and decisions about medical therapies. A priority is to FDA’s foods program, which will require sufficient funds from Congress to support something like a “21st century cures” initiative for food similar to that enacted to modernize and enhance the agency’s oversight of medical products in 2016. Under the current system, Califf noted that food producers don’t even have to tell FDA if they find contaminants in products awaiting shipment, limiting the agency’s ability to anticipate serious supply problems, such as the ongoing infant formula crisis.

At the same time, Califf defended the agency’s “appropriate” engagement with regulated companies as valuable for evaluating “the promise and risk” of new products and technologies. The broad knowledge of FDA staff about the full range of products in development—including many failures—can help guide developers to efficient pathways and prevent wasted and duplicative efforts, including clinical trials that could harm human subjects.

Similarly, Principal Deputy Commissioner Janet Woodcock urged a better understanding of the challenges and difficulties surrounding the many regulatory and scientific decisions made by FDA staff and leaders in another address at FDLI, which acknowledged the agency’s serious error in approving long-release opioids for market. Woodcock noted that a science-based regulatory process, as at FDA, has to issue regulations and policies that implement laws, a process that involves interpretation and inevitably generates dissent. Although science aims to assess the facts, many decisions are “surrounded by a cloud of uncertainty,” she said. Consequently, FDA’s critical approval of long-release opioids in 1995 was based on projections of harm and prescribing behavior presented at the time that were way off, Woodcock conceded. However, she acknowledged being pessimistic about this situation improving in the near future unless scientists and policymakers are able to communicate more broadly about the “big picture” of the uncertainty that inevitably surrounds agency decisions.

Califf raised similar concerns about “the growing dissemination of misinformation and disinformation about science, medicine, and the FDA, which is putting patients and consumers at risk” at the FDLI conference and also at the BIO International Convention in San Diego. Misinformation, he told biotech leaders, is the leading cause of death in the US, noting that almost all COVID-19 deaths now are preventable if patients become fully vaccinated and boosted. Misinformation, moreover, hampers the appropriate use of effective treatments for chronic diseases. It is paradoxical, Califf noted at BIO, that even though America is “innovating for the world,” US life expectancy is low, especially compared to other wealthy nations.

Califf observed at FDLI that he agreed to return to FDA last year after a previous stint as the agency’s leader in hopes of helping to modernize agency operations to prevent future critical delays and product shortages. This is a “pivotal moment” for the agency’s future effectiveness, he said, emphasizing that changes are needed to “stay ahead of the industries we regulate and the technology, science, and communications those industries employ.”

https://www.fda.gov/news-events/speeches-fda-officials/remarks-commissioner-califf-2022-fdli-annual-conference-06142022

Articles

Agency leaders seek to build public trust in science and gain support for regulation.

A Defining Period for Future of FDA

A broad bill carrying multiple proposals for revising and expanding FDA programs and policies, in addition to reauthorizing user fees critical for funding FDA operations, was endorsed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week. The legislators approval of the FDA Safety and Landmark Amendments (FDASLA) by a 13-9 committee vote sets the stage for full Senate reauthorization of industry fees to support oversight and development of prescription drugs, generic drugs, biosimilars, and medical devices.

The measure adopts a host of new programs and requirements that stand to make significant changes in how FDA regulates a range of medical and food products. However, many of the specific additions and revisions in the Senate bill differ from legislation already passed by the House as the FDA Amendments of 2022 (HR 7667).

 The situation requires the legislators to reconcile the two measures in order to enact final legislation by the current target of Aug 1.

The extensive Senate HELP bill builds on a discussion draft and updated package backed by HELP committee chair Patty Murray (D-WA) and ranking Republican Richard Burr (R-NC).

 An important provision backed by Murray clarifies the pathway for importation of drugs from Canada, expanding the range of eligible products. Murray also endorsed new proposals for strengthening FDA oversight of cosmetics and dietary supplements, which establish a broad range of new requirements and regulatory processes for these products. In addition, the VALID (Verifying Accurate Leading-edge IVCT Development) Act backed by Burr updates FDA policies for authorizing 

 diagnostics, with an eye to enhancing the agency’s ability to evaluate effective lab tests in public health crises.

Moreover, the legislators moved to address the current infant formula crisis by establishing an Office of Critical Foods in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). It provides a premarket review process for manufacturers of infant formula and requires FDA notification of production disruptions and recalls and switches to appropriate substitutions. A number of FDA reports to Congress on the program are included, along with revised procedures for FDA’s mailroom operations to prevent the loss of whistleblower reports and other important documents related to these and other regulated products.

Additional sections of the bill offer a range of enhancements for testing and marketing drugs and medical products. The development of treatments for rare diseases gains support from a new pilot program and other provisions. Competition from generic drugs may be enhanced by authorization of labels with certain differences from brands, while import is permitted for certain medical devices made overseas. FDA’s accelerated approval pathway is updated to ensure its support for innovative cardiology and neurology therapies, as well as cancer treatments. Added provisions aim to discourage the use of animal tests in developing drugs, cosmetics and other products. And FDA is required to move forward with policies to authorize over-the-counter hearing aids.

Important to FDA officials are provisions designed to expedite and simplify agency hiring practices and its ability to retain talented scientists and medical personnel. At the same time, the legislators extend oversight for FDA’s IT modernization program, requiring reports and clear goals and priorities to ensure that the added funds requested for this agency-wide initiative are effective and well-spent.

The wide scope of the legislation is not surprising, given the long history of policymakers adding multiple pet initiatives to this must-pass measure. As fees from regulated companies have become a main source of support for FDA oversight of the testing and development of critical medical products, the challenge remains to continue this financial support for the agency without enacting measures that will overload or undermine FDA and industry operations.

https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667eh.pdf

https://www.help.senate.gov/imo/media/doc/FDASLA%20manager's%20amendment%20SXS.pdf

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access. 

FDA User Fee Legislation Advances in Senate

A new framework for extrapolating clinical trial data from adult studies seeks to facilitate the testing and approval of therapies for children more quickly and at less cost. The process for achieving such gains is presented in a draft guideline recently released by the International Council for Harmonization (ICH) that maps out common methods and strategies for identifying how development programs for adult drugs can inform pediatric indications. By establishing common regulatory requirements among regions, the initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

The proposed pediatric extrapolation guideline (ICH E11A) was released by ICH in April to gain broader review and assessment by regulatory authorities and drug development sponsors around the world.

 This harmonization process began in 2017 and now appears on track to adopt a final guideline in 2024. An ICH assembly in Korea in November is slated to discuss this and several other proposed standards moving through the review process, such as quality risk management and analytical validation requirements, and newer projects on structured product quality, stability testing, and model informed drug development. In recent years, ICH has adopted guidelines on estimands and sensitivity analysis in clinical trials and on reproductive toxicology testing to support clinical studies; a newer initiative aims to update the E8 guideline on the conduct and reporting of clinical trials by incorporating quality-by-design principles into clinical research.

ICH also is moving forward with an initial roadmap for developing guidance on model-informed drug development (MIDD), considered a key approach for achieving a more efficient and more predictive clinical research process, with potential for reducing unnecessary patient exposure. The MIDD discussion group released a plan on March 31that lays out general principles, anticipated gains, time frames and options.

 The aim is to develop a general principles guideline in the next three-to-four years and a completed standard in 10 years. That would set the stage for revisions in several basic guidelines, such as on dose response information, population pharmacokinetic-pharmacodynamic studies, and disease progression modeling.

The ICH initiative on pediatric extrapolation was outlined at a public meeting on May 11 organized by FDA and Health Canada to update stakeholders on that and several other ICH projects.

 Lynne Yao, director of FDA’s Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research (CDER), described ICH efforts since 1994 to establish common global regulatory standards designed to provide children with access to medicines appropriately evaluated in adults and to support the inclusion of pediatric patients in product development programs where appropriate and feasible.

These initiatives for advancing pediatric clinical investigations have expanded since publication in 2000 of the initial ICH E11 guideline on pediatric clinical investigations. An addendum, E11 (R1), appeared in 2017 and recognized the need for more detailed standards on pediatric extrapolation. In response, an expert working group was formed to develop a reflection paper on the need and scope of an ICH E11A guideline on pediatric extrapolation. Initial steps involved aligning terminology and developing a systematic approach for considering study design, statistical methodologies, and modeling and simulation strategies in this area, Yao explained.

Now a draft, ICH E11A guideline provides a framework for utilizing pediatric extrapolation methods to meet regulatory standards for approval. It outlines a systematic approach for pediatric extrapolation studies that involves a full assessment and synthesis of existing data; quantitative predictions on the degree of similarity; development of a framework for potential reduction of required evidence; and later revision of uncertainties and assumptions. Pediatric extrapolation plans would consider patient response to treatment and identify gaps in knowledge involving dose selection, types of efficacy studies, and the need for a safety plan. The goal is to achieve more alignment among regulatory authorities on terminology and what study designs, statistical methodologies, and modeling and simulation strategies will advance pediatric extrapolation in drug development.

ICH standards for pediatric extrapolation, moreover, may help address broader concerns about the scope and extent of data extrapolation to support added indications for new drugs in patients not studied in original pivotal trials. While authorities generally agree that such extrapolation is valid and important for extending disease treatment to added patient populations, some experts question whether sponsors over-rely on limited clinical data to support added indications. This issue was highlighted in the recent debate over the extrapolation of limited clinical evidence in approving the Alzheimer’s disease treatment Aduhelm for patients with mild cognitive impairment. While experts agree that FDA and sponsors should have flexibility to expand an indication of an approved drug based on extrapolation of initial clinical data, pressure has increased for requiring post-approval studies to support such actions and to provide clear evidence of appropriate use.

https://database.ich.org/sites/default/files/ICH_E11A_Document_Step2_Guideline_2022_0404_0.pdf

https://database.ich.org/sites/default/files/ICH_E11A_Step_2_Presentation_2022_0404_0.pdf

https://admin.ich.org/sites/default/files/2022-05/ICH_MIDD_Roadmap_2022_0503.pdf

https://sbiaevents.com/files2022/ICH-Spring-2022-Agenda.pdf?utm_medium=email&utm_source=govdelivery

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

New Guidelines Aim to Advance Pediatric Drug Development

Although FDA announced in Februarythat it was resuming “normal, routine domestic surveillance” of drug and medical product manufacturing facilities, many of the innovations and modifications for site inspections adopted during the COVID-19 pandemic will continue to play a visible role in agency compliance and enforcement operations. FDA’s Office of Regulatory Affairs (ORA) delayed or cancelled most on-site inspections during the past two years due to travel restrictions and infection concerns, but now seeks to resume active inspections where needed and practical.

This shift, however, does not signal an end to FDA’s wider use of paper document reviews and of virtual site visits, or remote interactive evaluations (RIEs), in ramping up oversight of biopharma manufacturing and research operations. These strategies notably reduced agency inspection costs, while enabling timely detection of compliance issues, and FDA sees value in continuing its expanded reliance on documents and records, on inspection reports from trusted regulatory authorities, and on wider use of remote real-time review of records and plant operations to provide assurance of proper manufacturing and clinical research operations.

Judith McMeekin, associate commissioner for regulatory affairs, pointed out during a presentation sponsored by the Alliance for a Stronger FDA on April 6 that ORA saved nearly $40,000 in 2020 and 2021, providing resources to develop a foreign travel planning system, expand personnel training, enhance information systems, and upgrade labs. FDA analysts are comparing the benefits and shortcomings of onsite inspections vs. record requests in order to develop criteria for revising or continuing these alternative practices.

More flexible inspection programs could gain from legislation before Congress to reauthorize FDA user fees and update agency operations and policies. The bill includes a provision to clarify FDA’s authority for collecting manufacturing records from medical device makers in advance or in lieu of field inspections and also for clinical study sites under the agency’s bioresearch monitoring program (FDA already has such authority for drugs). The measure also clarifies agency use of inspection findings of trusted foreign regulatory authorities in determining the need for preapproval inspections (PAIs). The bills requires FDA to post more information on the findings from drug and device inspections, such as warning letters and import alerts. And to expand unannounced FDA inspections of foreign drug establishments, the legislators propose a new pilot to increase such site visits and to evaluate the impact on both domestic and foreign facilities.

In response to these developments, FDA has worked to better explain its criteria for selecting and methods for conducting more remote and alternative facility assessments. At the recent FDA Generic Drugs Forum, staffers from the Office of Pharmaceutical Manufacturing Assessment (OPMA) in the Center for Drug Evaluation and Research (CDER)’s Office of Product Quality (OPQ) explained that FDA will weigh the need for an on-site inspection based on a risk-based assessment of product, process and facility risks.

 This involves scrutiny of records and other manufacturer information from trusted regulatory authorities.

Such information on a firm’s compliance history, process risks, manufacturing experience, and previous alerts, recalls, and complaints will help determine whether a PAI is needed or if FDA can assess the company’s capacity for risk mitigation and GMP compliance from company and regulator records. When FDA considers an RIE advisable, it will discuss the logistics, scope, and expectations with the manufacturer, request needed documents from the firm in advance, and outline its main questions or concerns and the logistics for conducting a remote facility tour. Such virtual site visits also can help all parties prepare for a future on-site inspection, if warranted, but do not qualify as formal inspections 

. They are voluntary for the company, but a refusal to cooperate with an RIE request can delay product approval.

OPMA Staff Fellow Alexander Gontcharov described an RIE for a foreign manufacturing facility utilizing a new unit of operation to produce delayed release tablets and capsules. This involved four three-hour sessions with a facility “walk-through” using a laptop on a cart with external cameras and microphones. Another RIE for a new unit producing new ointments and liquid products had three four-hour sessions that used a portable tablet PC with Wi-Fi connections. FDA investigators viewed warehouses, labs, and production areas, as well as document control systems. Inspection findings may be specified in a close-out memo, or FDA may later send a letter identifying difficulties found at the facility and if an on-site inspection is needed.

The shift to remote assessments is reflected in the rise of warning letters that involve alternative inspection tools, according to the 2021 annual report from CDER’s Office of Compliance (OC).

 While FDA exercised enforcement discretion in multiple cases to avoid shortages of critical medicines, OC reports a rise in drug adulteration warning letters based on sample testing and on information from records requests. In addition, OC conducted more than 45 remote regulatory assessments (RRAs) of clinical sites under the agency’s biomedical research compliance program. An FDA draft guidance published in April 2021 advises manufacturers on how the agency seeks to conduct this growing range of remote evaluations.

Overall, FDA advises manufacturers to recognize the importance of RIEs and to query about any unclear agency information requests. While FDA recognizes that RIEs are not equivalent to full inspections and that the agency only can see what the firm makes available, these alternative tools have cut the need for on-site PAIs in half and helped the agency meet user fee approval goals for 90% of applications this past year.

https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022

https://www.fda.gov/media/150036/download

https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Section%20by%20Section_The%20Food%20and%20Drug%20Amendments%20of%202022_5.4.2022.pdf

https://sbiaevents.com/files2022/GDF-2022-Agenda.pdf

https://www.fda.gov/media/157954/download

https://www.fda.gov/news-events/press-announcements/fda-provides-guidance-remote-interactive-evaluations-oversight-drug-facilities-during-covid-19?utm_medium=email&utm_source=govdelivery

Plan to keep new methods adopted during COVID in place.

FDA to Continue Inspection Efficiencies After Pandemic

FDA officials have faced a range of tough questions on Capitol Hill in recent weeks as part of the process for gaining timely agreement on legislation to reauthorize user fees for the agency’s medical product regulatory programs. Last week, members of the Senate Health, Education, Labor & Pensions (HELP) Committee quizzed Center directors for drugs, biologics and medical devices on multiple contentious issues—expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives, to name a few.

Less was said by most members of the HELP Committee about the specific provisions in the new user fee packages for drugs (PDUFA), generic drugs (GDUFA), and biosimilars (BsUFA), which were summarized in written testimony by Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni and Center for Biologics Evaluation and Research (CBER) Director Peter Marks.

 A delay in finalizing the agreement on medical device user fees (MDUFA), however, drew sharp criticism from the committee’s ranking Republican, Sen. Richard Burr (R-NC). And Burr questioned whether added fee payments really will enable these key FDA operations to actually reduce sizeable staff vacancies, as new hires have failed to offset even larger attrition rates at the agency.

Several senators challenged FDA’s approval of Aduhelm to treat Alzheimer’s disease and the equally controversial decision by the Centers for Medicare and Medicaid Services (CMS) to limit access to the drug to those Medicare beneficiaries enrolled in postapproval clinical trials. Cavazzoni was adamant about the validity of FDA’s approval of the drug, while also seeking Congressional support for legislation enabling FDA to require manufacturers to start confirmatory trials at time of drug approval, to meet agreed-on timelines and milestones for such studies, and for authority to expedite the market withdrawal of drugs that fail to show benefit in postapproval trials.

In response to queries about a recent court decision involving the Orphan Drug Act, Cavazzoni warned that the ruling “will send a chill” into the development of rare disease treatments, especially for children. That discussion involves the finding in the case of Catalyst vs. FDA by the US Court of Appeals in October 2021 that FDA cannot approve a pediatric version of a drug that has obtained orphan drug exclusivity for the adult version. That ruling, said the CDER director, enables a company to develop a drug for a very narrow patient population and then use the exclusivity for the initial approval to block further research on the therapy for other conditions and patients. The controversy may prompt legislative action or end up for review by the Supreme Court.

The increasingly contentious debate over FDA regulation of access to the abortion pill mifepristone also gained a hearing, as Sen. Roger Marshall (R-Kan) warned that patients will be harmed by recent changes in FDA rules that permit access to the drug through telemedicine, as opposed to requiring a visit to a doctor’s office. Marshall cited the potential for severe complications if women take the pills too late in pregnancy, which he said is more likely without an in-office ultrasound examination. Cavazzoni responded that FDA’s “exhaustive review” of the drug indicates that current procedures ensure its safe use, and that an ultrasound examination is not required. Requests for pills to terminate pregnancy have risen recently as states enact increasingly severe limits on abortions, despite parallel efforts to discourage mifepristone use. FDA’s more flexible position on the issue is expected to be a target for legislation backed by anti-abortion groups.

And in response to a query from Committee chair Sen. Patty Murray (D-Wash) about delays in access to vaccines for children under 6, Marks of CBER said that FDA action on such a vaccine was a “top priority,” that the agency was waiting for manufacturers to file EUA applications, and that CBER would discuss such preventives at a public advisory committee meeting; a highly transparent discussion, said Marks, was important for building public trust in the safety and effectiveness of any preventive for very young patients. CBER’s subsequent announcement that such committee review would not occur until June, however, prompted loud protests about FDA delaying access to vaccines important for keeping very young patients healthy.

The tone and scope of the questioning of FDA officials here and at earlier hearings by the House Committee on Energy and Commerce provide a glimpse of what measures Congress may tag on to the user fee reauthorization package. The outcome of months of discussion will emerge more visibly this month as the process moves forward to “mark up” a legislative proposal that includes all the user fee packages and leading add-on measures. All parties would like to see Congress vote on user fee legislation before its annual recess in August, but the schedule is tight, and the scope of pet initiatives expands every day.

https://www.fda.gov/media/157948/download

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Congress Presses FDA on Key Policies and Operations

FDA recently issued a new guidance on how to make clinical research more inclusive, building on earlier, broader advisories on the topic. At the same time, Congress is looking to advance legislation promoting clinical trial diversity in pre- and post-market studies, while the latest revision to drug user fee programs includes provisions for advancing clinical trial diversity in sponsors’ R&D programs. These initiatives fit the Biden administration’s broader goal of addressing racial and ethnic health care disparities through a range of public research and coverage programs.

This latest FDA draft guidance follows its advisory on “Enhancing the Diversity of Clinical Trial Populations” published in November 2020. That final guidance supported efforts to expand eligibility criteria and improve enrollment practices and trial designs so that clinical studies would better reflect the population most likely to use the drug if approved.

The specific aim here is to clarify how sponsors should submit a “Race and Ethnicity Diversity Plan” with applications proposing clinical research or continuing with trials to support the approval of drugs, biologics, and medical devices.

 The draft guidance encourages early submission of such plans to present strategies for enrolling and retaining diverse patient populations in trials. FDA advises sponsors to discuss such research proposals as early as possible during the investigational new drug (IND) stage, and certainly before launching pivotal Phase III studies.

FDA defines a “diverse population” as including demographic factors such as race, ethnicity, sex, gender identity, age, pregnancy, or lactation status, and the presence of additional comorbidities. Sponsors should set enrollment goals for a full range of populations in order to obtain relevant pharmacological and genomic data that can help design larger studies appropriately. The guidance also outlines patient retention strategies, which may involve collaboration with community health workers and patient advocates and reimbursement for expenses to participants in need. FDA advises sponsors to consider the location and accessibility of research sites as part of diversity planning and to design programs for reaching out to patients often reluctant to participate in medical research.

Efforts to achieve greater diversity in research “will be a key focus throughout the FDA,” stated FDA Commissioner Robert Califf, noting the importance of effectively fighting diseases that often disproportionately impact minority communities in announcing the new proposal. These regulatory efforts support the Biden administration’s Cancer Moonshot initiative, which aims to address inequities in access to cancer screening, diagnostics, and treatment across race, gender, region, and resources. The new guidance was developed by staff of Project Equity at FDA’s Oncology Center of Excellence (OCE), which seeks data supporting the approval of oncology therapies that fully represent all patients in need of treatment.

Congress also is likely to consider legislation on this issue as part of a broader measure to reauthorize FDA user fees that is moving forward on Capitol Hill. A bipartisan bill supported by leading members of the House Energy and Commerce Committee aims to enhance FDA’s authority to require that drug and device applications include demographic information on the population to be treated and to enroll such groups in clinical research programs. The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act further authorizes FDA to require sponsors that fail to meet diversity enrollment targets to obtain that data in post-marketing studies.

The 2.0 update to the 21st Century Cures Act similarly calls for FDA and other federal health agencies to advance diversity in clinical trials through added research and policy-making activities. And the latest version of the Prescription Drug User Fee Act (PDUFA VII) sets goals for sponsors to enhance clinical trial diversity, particularly in the development of new cancer therapies.

FDA aims to further encourage diverse clinical trials through research projects to explore best practices for achieving these goals. One proposal is to learn more about which populations are most affected by research that fails to address diversity issues. Others look to better define “health diversity” and how to determine when a specific population or group is most adversely affected by inequities in treatment and research. Sponsors would like more advice from FDA on how to respond when unable to enroll fully representative populations in studies, and what data is most important to collect. Goals may differ for research programs that involve very few patients, as seen in efforts to extrapolate race and ethnicity data from limited studies. An important issue is how FDA and sponsors should consider clinical data from research sites outside the US. FDA has requested that stakeholders submit comments by June 13 on these and other topics raised in the guidance document.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.