Policy and promises: Tracking Makary’s first year running the FDA

Over the past 12 months, FDA Commissioner MARTIN MAKARY has set in motion or announced a long list of substantive policy changes, with some in effect and others seemingly half-finished or stalled. With Makary marking his first full year as Commissioner this week, AgencyIQ wanted to take stock of what he’s accomplished, what’s partially finished, and where promises of action have fallen short.

Makary’s tenure as FDA commissioner: A quick overview and our approach to assessment

• FDA Commissioner MARTIN MAKARY has been commissioner for one whole year. Following a confirmatory U.S. Senate vote on March 25, 2025, Makary assumed the role after a private swearing-in shortly thereafter (likely March 28), according to reporting by POLITICO and The Pink Sheet. The FDA announced Makary’s swearing-in via an April 1, 2025 press release. He arrived at an agency actively undergoing the trauma of HHS-wide layoffs that ultimately shrank the FDA’s workforce by thousands of employees and contractors, and his initial weeks and months on the job were consumed by managing disruption caused by the reduction in force and convincing stakeholders that the agency could manage through it.
• Even so, Makary quickly began making major policy announcements intended to demonstrate his commitment to reforming the FDA. In his first three months alone, Makary rolled out a plan to reduce animal testing, scaled up the agency’s foreign inspections program, adopted a new framework for approving COVID-19 vaccines, fast-tracked the launch of a cross-center AI assistant and created a new expedited review process for products that address national health priorities. He’s since moved to shift long-held agency norms, including reducing the default number of pivotal trials required for drug approvals from two to one and proactively publishing some Complete Response Letters. And under his leadership, the FDA has substantially eased biosimilar testing requirements, designed a regulatory framework for individualized therapies and begun consolidating its various adverse event monitoring systems.
• While these are all substantive changes, their impact has varied considerably. Some are already in effect, while others remain policies that exist only in press releases – or sometimes podcasts and podium proclamations – rather than in practice. For instance, he’s promised a sweeping regulatory crackdown on direct-to-consumer drug advertising, signaled a coming “mass transition” of prescription medicines to over-the-counter availability and talked up a grand vision for continuous trials. While all three plans appear to be in motion, Makary’s rhetoric on each has outpaced actual agency accomplishment. He’s also seeking reforms that would make the U.S. research ecosystem more competitive to China’s and bring an “America First” structure to the agency’s user fee system.
• All the while, persistent leadership upheaval has undercut the FDA’s policy actions and caused turmoil that threatens to engulf Makary’s tenure as commissioner. VINAY PRASAD, Makary’s hand-picked Center for Biologics Evaluation and Research director, has been forced to leave the agency twice over controversial decision-making. The FDA’s other principal drug review center, the Center for Drug Evaluation and Research, has had five acting or permanent directors under Makary, including GEORGE TIDMARSH, who departed amid an HHS investigation for alleged ethical lapses. One of Makary’s top deputies was briefly asked to resign by the White House after inappropriately assuming a higher title, while the agency’s deputy chief of staff is reportedly under investigation for potentially misleading government ethics officers, according to Bloomberg. Even before Prasad’s planned second departure from the agency, Makary was reportedly in a “power struggle” with HHS Secretary ROBERT F. KENNEDY JR. over his management of the FDA, according to POLITICO. Kennedy recently elevated the FDA’s top policy official and head of human foods to roles within HHS that include oversight of the FDA.
• Rather than assess the importance or value of each of Makary’s efforts, we instead want to take concrete stock of how the FDA has changed in the last year, and forecast what other changes could soon be on their way. Thought pieces explaining how Makary has changed the FDA in subjective terms will be plentiful. We wanted to really explore what has changed in objective terms – or as close as we could get to them. Our list excludes items that Makary has previewed as coming soon but have not yet been officially announced.
• The following list does not include all actions taken by the FDA during Makary’s tenure to date. Instead, AgencyIQ has selected the initiatives Makary has most prominently championed – either through his bully pulpit or by direct involvement in their formation. (For an overview of guidance documents the FDA has issued over the same time, please refer to this tracker.)

Notable Makary initiatives: Announced policies and changes already in effect

The following changes, announcements and policies are already in effect and generally operational in current form, though further changes may come.

• Complete Response Letters: The FDA’s decision to publicly release CRLs – letters indicating an application for approval or licensure will not be approved due to specific reasons – for unapproved drugs on its openFDA site is among the most notable of Makary’s reform actions. The FDA had long pushed for this action, though many observers thought CRL release would not be possible without congressional action. The FDA released two major batches of CRLs in 2025 and has continued adding redacted letters to the repository in something like to a real-time cadence. [AgencyIQ has extensively analyzed these documents for trends and insights: See Part 1, Part 2, Part 3 and Part 4.]
• The Commissioner’s National Priority Voucher pilot program: Perhaps Makary’s signature program, the CNPV mechanism aims to provide a 1- to 2-month review and enhanced communications for drug programs designated with a newly created voucher. Products must fall within at least one of five priority categories: Public health crisis response, innovative breakthrough therapies, large unmet medical needs onshoring and supply chain resilience and affordability. The agency has fielded applications from sponsors and reviewers, unveiling the first two batches of voucher recipients last fall. Vouchers have now been awarded to 18 products targeting a range of diseases and at various stages of development. In some ways, the agency has been building the CNPV plane as it flies. Following its first approval under the CNPV program in December 2025, the agency provided extensive new and refined documentation about the program in February, likely in response to criticism the program received. As of April 1, the FDA has approved five products in the program and issued one Complete Response Letter. [See AgencyIQ’s CNPV Tracker here.]
• Easing biosimilar study requirements: Among the more high-impact of Makary’s changes are efforts to reduce the amount of testing required for biosimilar product approvals. New FDA draft guidance lifts the default requirement for comparative efficacy studies in favor of allowing a “streamlined approach” relying on comparative analytical assessments, pharmacokinetic studies and immunogenicity assessments. Second, the FDA plans to stop requiring “three-way” pharmacokinetic studies by default when ex-U.S.-licensed products are used as the comparator – a change that will reduce the studies’ complexity and cost. Though the documents remain in draft form while the agency solicits feedback, we think FDA will likely move toward the new data standards even before the documents are finalized.
• Filing checklists: In October, the FDA announced it was making filing checklists, which its internal staff use to ensure applications are ready to be reviewed, publicly available in a bid to improve industry’s success in filing complete applications. CDER released this checklist in October, and CBER followed suit in December 2025.
• Movement toward Makary and Kennedy’s product-specific wishes: Throughout 2025 and early 2026, the FDA has taken extensive action to make drug labeling changes that address the whims and wishes of Makary and HHS Secretary ROBERT F. KENNEDY JR. Makary convened an “expert panel” last July to discuss making labeling changes for hormone replacement therapy for women – and then the FDA made the change in February. Labeling changes were initiated for acetaminophen last September to reflect a heavily disputed FDA claim of a potential linkage between autism and use during pregnancy. FDA pushed for a new approval for leucovorin to treat “autism symptoms,” then approving the product in March, albeit for a sharply limited indication for a rare condition. All three actions would have been practically inconceivable under prior FDA leadership, but they provide strong evidence that the FDA under Makary is more willing than ever to allow the commissioner and HHS leadership to drive individual product approval and labeling change decisions.
• Meeting minute pilot: In November 2025, the FDA announced a new pilot program intended to help “streamline communications with sponsors following formal meetings” with CDER’s Office of New Drugs by allowing sponsors to ask clarifying questions. The FDA said it had been using the pilot program even before it was announced. We haven’t heard much about the program since its launch, including if it’s been expanded to other centers or offices, but this program remains in effect as best we can tell.
• Through its “Expert Panel” series, the FDA has held public meetings on regulatory topics faster and with less expense than incurred when convening its advisory committees. The agency has hosted six panels total, with four occurring between May and July 2025 (talc, infant formula, hormone replacement therapy and SSRIs in pregnancy). The series has since tapered, with additional meetings held in December 2025 (testosterone replacement therapy) and February 2026 (food allergies). While Makary is supportive of the panels, the decision to forgo most advisory committee meetings has attracted significant scrutiny, including for selecting panelists with extensive conflicts of interest and potentially violating federal law and minimizing public input in decision-making processes.
• The FDA Direct Podcast, intended for a lay audience, launched in May 2025 with the intent to improve transparency into FDA decision-making. In total, Makary and other FDA officials have participated in 24 podcast episodes. Episodes were released steadily every few weeks throughout the summer and early fall, with frequent cohosts including Prasad and SANJULA JAIN-NAGPAL, the agency’s associate director of policy and research strategy. The content often provided additional detail on new announcements or previewed policy changes to come [See select AgencyIQ analyses of episodes here, here and here]. Podcast episode release has since become less frequent and predictable, with the most recent episode marking the agency’s Rare Disease Day activities on Feb. 23

Notable Makary initiatives: Announced with ongoing or incomplete actions

Many of the actions announced by Makary remain works in progress. In general, these are announcements of important changes and initiatives, but for which the action is still half-finished or pending.

• Direct-to-consumer drug advertising: In September, the FDA announced what it called a “crackdown on deceptive drug advertising” promising heavier scrutiny of advertising by drugmakers and biopharmaceuticals companies. It also planned to withdraw a major regulation that permits drug companies to air brief advertisements on television and the radio. While the FDA has begun something of a crackdown on drug advertising, this effort as a whole remains a work in process. The vast majority of FDA actions against companies have been Untitled Letters (and a few Warning Letters), which only ask companies for voluntary compliance. The FDA still hasn’t taken action against persons or companies on “digital and social media channels,” a promised enforcement action. It hasn’t taken legal action against companies, either on its own or in partnership with the Federal Trade Commission. And critically, it still hasn’t withdrawn its “adequate provision” regulation.
• RIFs and hiring: One of the first actions Makary oversaw upon being sworn in was a massive downsizing of the FDA’s workforce through reductions in force, early retirements and attrition. Though Makary was able to undo some of the RIFs in specific instances (such as bringing back some policy staff and staff supporting foreign inspections), and has repeatedly pledged to hire (and in some cases rehire) about 1,000 employees, it’s clear that the FDA is a far smaller workforce than the one he inherited last March. According to FDA workforce data from January, the FDA lost a net 3,870 employees in FY 2025, and has lost 587 total workers in FY 2026. Though Makary’s efforts to hire new FDA reviewers remain ongoing, it remains to be seen whether his efforts will be able to outpace the departure of other FDA staff who regularly cycle out of the agency.
• The “plausible mechanism” pathway, which aims to adjust evidentiary standards for individualized therapies treating ultrarare conditions in a bid to make it easier for treatments to come to market, was officially unveiled in February in a guidance document. However, the pathway remains in draft form and doesn’t appear to yet be operational. Criticism of the pathway has come from several quarters, including some of the very scientists who featured in FDA’s public announcement of the pathway. These researchers claim existing onerous manufacturing requirements could still box out the academic medical centers that are most likely to make of the pathway’s clinical trial design flexibility. The FDA also hasn’t yet published any staff guides or manuals to help reviewers use the pathway.
• Updated vaccine regulatory frameworks: In late November, CBER Director Vinay Prasad announced to staff that the center would be adopting a new approach to regulating vaccines. The memo called for a revised annual flu vaccine framework, risk assessment of giving multiple vaccines at once, scrutiny of specific types of vaccines, and more. The memo came after Prasad and Makary published a framework for Covid-19 vaccines in a New England Journal of Medicine “Sounding Board” piece that includes enhanced scrutiny of Covid-19 vaccine studies. To date, implementation of this policy has been patchy. The FDA has already added new safety warnings to Covid-19 vaccines, initially refused to file an influenza vaccine appliation, and added new warnings to several other vaccines. But there are signs that the most significant actions are still to come, with several major FDA guidance documents on CBER’s annual guidance agenda addressing data needed to support vaccine licensure, testing vaccines in pregnant women, evaluating combination vaccines, and more. The FDA also still hasn’t released data Prasad said shows that Covid-19 vaccines were responsible for the deaths of “no fewer than 10” children.
• A digital health policy revamp has been underway during Makary’s tenure and gathering speed. In early 2026, FDA released two revised final versions of guidance documents that were originally published in 2019 (“General Wellness: Policy for Low Risk Devices”) and 2022 (“Clinical Decision Support Software”). Both documents were updated to expand areas where the FDA intends to exercise “enforcement discretion” in not enforcing certain regulatory requirements. In the new guidance documents, FDA allows new regulatory flexibility for certain sensor-based wearable products and defines a new category of enforcement discretion for CDS products that provide “only one option.” Further changes are expected in 2026, with CDRH planning to release an updated policy for device software functions – all part of Makary’s goal to make the agency’s digital health guidance documents shorter by “about 50% or more and make them more clear, more concise, more modern, and more consistent.” The FDA is also operating a pilot program in collaboration with the Centers for Medicare and Medicaid Services called TEMPO. This ongoing pilot allows certain digital health products to bypass FDA authorization in order to generate real-world data, which will then be used to support a marketing submission.
• Expanded use of real-world data and evidence has been another priority area for Makary, as initially detailed in a JAMA viewpoint outlining his and Prasad’s “priorities for a new FDA” that listed “Big Data” as a key point of interest. Throughout the last year, Makary has spoken repeatedly about enhancing use of RWD for regulatory purposes. In December, FDA announced that it had “removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews,” stating that the agency would no longer require patient-level data in RWE analyses. However, the document referenced was an update to the FDA’s guidance document on RWE for medical devices, which was finalized shortly thereafter. The issue of patient-level data access was not a primary focus of that final guidance and, as AgencyIQ noted at the time, it was already existing policy for medical device submissions. While Makary indicated that drug product submissions would also be exempted from patient-level data requirements – a significant policy change in drug regulation – the FDA hasn’t provided additional information for drug developers on this topic.
• Expansion of the Foreign Unannounced Inspection Pilot was an early priority for Makary, who said the effort was about fixing a “double standard” which put foreign manufacturers at an advantage over domestic ones. And one year later, the pilot program is starting to show results, though they may not be as dramatic as Makary had hoped. In response to questions from AgencyIQ, the FDA said it conducted 233 unannounced foreign inspections in FY 2025, about 45% more than the 161 that were conducted in FY 2024. Comparing those figures to the agency’s compliance dashboard, that means about 90% of the 2,370 foreign inspections the FDA carried out in FY 2025 were declared beforehand. In FY 2024, about 94% were. Unannounced inspections took place in at least 21 countries over the past two years, including China and India, according to the agency, which did not distinguish by product type. (About three-quarters of all foreign inspections over the past two years involved food or cosmetics facilities.) That’s certainly progress, but we’re a long way from achieving parity between domestic and foreign manufacturers.
• New alternative methods, or non-animal testing models, have been heavily promoted by Makary’s FDA. But despite taking several high-profile actions, there’s still much for the FDA to do. First, what has happened: The FDA announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs, released a new guidance document on alternatives to animal testing (“General Considerations for the Use of NAMs in Drug Development”), issued new guidance to reduce the use of non-human primate toxicity testing for monoclonal antibodies, and released a roadmap to reducing animal testing in preclinical safety studies. But there are a few reasons why this effort remains a work in progress. First, the FDA still hasn’t updated its regulatory requirements for animal testing under the FDA Modernization Act 2.0 of 2022. Second, the roadmap and guidance are nonbinding recommendations that encourage sponsors to make use of NAMs, but don’t necessarily require FDA to accept them in all cases, resulting in uncertainty for companies. We expect FDA will continue to advance NAMs in the coming years (and we should note FDA was working on these efforts long before Makary’s time there), but the regulatory changes under FDAMA 2.0 are the big change to look for.
• Compounding crackdowns: Commissioner Makary seems to be developing something of a complex relationship with the pharmaceutical compounding industry. He’s initiated a crackdown on compounded GLP-1 drugs using arguments that could easily extend to all compounding activities. FDA has warned more than 30 telehealth companies, primarily for misrepresenting themselves as GLP-1 compounders. FDA has warned other compounders for not following the agency’s advertising regulations, which they arguably aren’t required to follow. But there are also signs that FDA is about to give compounders a significant gift: The ability to compound 14 different types of peptides that FDA had previously characterized as being too difficult to compound.
• Continuous trials have been proposed as a strategy to make clinical trials more efficient by streamlining the stop-and-start of phase-based trial processes and implementing real-time data monitoring. Makary has regularly mentioned the concept in public appearances. The specifics of his plan remain open to interpretation, and there are plenty of practical challenges associated with Makary’s idea for continuous trials, including some previously identified by the FDA itself. For example, its expansion cohort guidance makes note of dozens of potential concerns, including the risk that rapid enrollment and the “evolving nature of the information obtained in these trials” may subject participants to harms from minimally characterized toxicity profiles in ways that slower, more deliberate enrollment might not. [Read AgencyIQ analysis here.] However, the FDA did release a draft guidance document on Bayesian methodologies in clinical trials that provides a clearer pathway for adaptive trials, including concepts that can support continuous trials.
• A new contracting approach previewed in a request for information reveals that the agency is considering direct relationships with venture capital firms for task orders. However, little else has been publicly discussed about this effort.
• Adverse Event Monitoring System updates: In September, the FDA teased the idea of consolidating the agency’s product-specific adverse event data systems into a single unified system to be known as the Adverse Event Monitoring System, or AEMS. The individual systems include FAERS, the FDA Adverse Event Reporting System, for drugs, biological products, cosmetics and color additives; AERS, for animal drugs and foods; the Human Food Complaint System, or HFCS; VAERS for vaccines; a tobacco database; and the Manufacturer and User Facility Device Experience, or MAUDE, database. In March 2026, FDA announced that it had begun to consolidate the systems into AEMS, and it planned to have real-time adverse event reports for all FDA-regulated products by the end of May 2026. The agency also announced in August 2025 that it was beginning daily publication of adverse event data from its FAERS system (now AEMS).
• Trials exporting cells: In June 2025, Makary announced that the FDA was immediately reviewing all clinical trials involving “sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients.” Since then, the FDA hasn’t publicly mentioned any additional actions or findings from this effort, and it’s not clear if the review resulted in any consequences for companies or specific clinical trials.
• An agency-wide AI rollout made multiple enterprise AI tools available to FDA staff, as detailed in a presentation during the agency’s Rare Disease Day event. These include both generative (Elsa) and agentic (Gemini) AI platforms – though a recent announcement by the White House requires the FDA to stop using Anthropic systems, a foundation for Elsa. Staff use of these tools for product review is in progress, though dispatches from groups like the Office of Oncologic Drugs indicate that AI-assisted workflows are still being performed in parallel with traditional review activities. [Read AgencyIQ analysis here.]
• Opioid labeling: Makary has frequently criticized prior agency commissioners as being relatively complacent when it came to the harms caused by opioids. So far, Makary has pushed for several opioid-related changes, including a new draft guidance intended to support development of non-opioid analgesics, pushing for development of specifications for in-home disposal systems for opioids, and requiring labeling changes to opioids to emphasize risks. While the labeling changes have been put in effect, all other aspects of this strategy remain in progress – either as draft guidance, specifications to be developed, or other strategies that have not yet been announced.
• The “FDA PreCheck” program was unveiled in August 2025 with an aim to “strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States,” according to a press release. As described in the Federal Register notice, its goal is to accelerate the establishment of drug manufacturing facilities in the U.S. by providing more feedback to would-be manufacturers during critical junctures related to the design, construction and qualification of a new facility located in the United States. The FDA is moving toward a June 1 deadline to select an initial cohort of facilities and, since March 1, has been reviewing applications to be included in the program. The next deadline is May 1, when finalists will be required to submit all requested final application information.

Notable Makary initiatives: Announced with minimal apparent action

The following actions have been announced but lack follow-up announcements or developments. To our best knowledge, they remain mostly incomplete or minimally in progress.

• FDA HHS Regulatory Review: Curiously, something the FDA has not done much of during Makary’s tenure as Commissioner is deregulation. As part of an April 2025 executive order, all federal agencies were ordered to review regulations for elimination. HHS and FDA even issued a RFI on a “deregulatory plan to lower costs and empower providers.” But to date, there is little sign of the impacts of this effort. While FDA has moved to deregulate some areas through guidance documents, increased enforcement discretion and medical device downclassification, vanishingly few regulations have been eliminated (and of those, most are related to food products). Even FDA’s Unified Agenda didn’t seem to include many deregulatory actions.
• Improving trust in the FDA: Most of the items on this list are incomplete, but Makary’s efforts to improve trust in the FDA appears to be demonstrably headed in the wrong direction. He has frequently claimed he is working to rebuild trust in the FDA, which he said suffered as a result of the Biden administration’s actions during the Covid-19 pandemic, among other issues. But according to a February 2026 poll fielded by the University of Pennsylvania’s Annenberg Public Policy Center, public trust in the FDA has actually fallen since Makary came into office. In February 2024, 74% of respondents said they were “very” or “somewhat” confident that the FDA was providing trustworthy information about matters concerning public health. In February 2025, just 67% of respondents said they were at least “somewhat” confident, and as of February 2026, just 62% did.
• State importation programs: Since the first Trump administration, the FDA has been trying to implement a program allowing importation of certain drugs from Canada through agency-approved state and tribal importation programs, also known as Section 804 Importation Programs. But despite initial FDA approval of Florida’s importation program, none of these efforts are operational. Further, it doesn’t seem like Canada is especially likely to facilitate drug exports that could exacerbate its own drug shortages and increase government spending. We mention this because on March 6, the FDA announced that it recently met with representatives from several states to discuss importation plans in a bid to help some of them obtain FDA authorization. FDA recently began allowing states and tribes to submit draft SIP for pre-review and is working to help them accelerate their cost savings analysis. It also launched a Quality Assurance Tool to help guide development of the plans. We could see more action soon, but to date, not much has changed.
• The Rare Disease Evidence Principles pilot has been described as an opportunity for selected sponsors to receive “assurance” that the FDA will consider a broader range of data for confirmatory evidence of drug effects. Announced by then-CDER Director GEORGE TIDMARSH in September 2025, the pilot was further described through a new webpage and FDA press release. With the exception of a passing reference in the Rare Disease Innovation Hub’s 2026 Strategic Agenda, there has been no word about how – or if – the agency has selected applications for participation in this program.
• Limits on industry participation in FDA’s advisory committee meetings was one of the first reforms Makary announced. An April 17, 2025 press release unveiled “a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed.” Almost a year later, there’s no publicly available document expressly spelling out the new restrictions and the meaning of key terms like “limits,” “employed,” and “official.” While the FDA convened limited advisory committees in Makary’s first year, many still featured active participation from nonvoting industry representatives.
• A move to a single pivotal trial default to demonstrate substantial evidence of effectiveness made waves in February 2026. “Going forward, the FDA’s default position is that one adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel products,” Commissioner Makary and CBER Director Prasad declared in a NEJM “Sounding Board” piece. AgencyIQ has previously pointed out that the majority of new molecular entities approved by the agency since 2020 already relied on a single pivotal trial. The leaders hedged against this critique in their piece, saying, “A wide body of literature suggests that default options anchor individuals and institutions psychologically, and we believe that formally articulating the FDA’s new position will spur biomedical innovation.” [Read AgencyIQ’s analysis of the new policy.] By the end of March, the FDA hadn’t incorporated this change in guidance, which will likely involve changes to key documents pertaining to foundational issues and confirmatory evidence.
• A “mass transition” of prescription drugs to over-the-counter status has been a major Makary talking point. He brought the topic up in his March 2025 confirmation hearings as well as in subsequent interviews. For example, in a Dec. 5 appearance on Fox Business, Makary indicated the agency is preparing to “move a lot of medications to over-the-counter,” including certain unspecified anti-nausea medications; in a Jan. 15, 2026 interview, he told venture capitalist and “All-In” podcast host David Friedberg that the FDA is seeking a “mass transition to more nonprescription drugs.” In December, the agency did put out a request for information on general and scientific questions regarding nonprescription drug regulation, and a public meeting on “increasing access to nonprescription drugs” is on the calendar for April. However, a policy action in this area has yet to be announced or implemented.
• Flexibility regarding chemistry manufacturing and controls requirements for cell and gene therapies was emphasized through a press release in January. The notice explained that the move did not change policy but rather communicated it broadly. VIJAY KUMAR, director of FDA’s Office of Therapeutic Products, explained, “CBER is proactively communicating about regulatory flexibilities that were previously applied case-by-case to select CGT therapies. It is vital that every sponsor, no matter the CBER reviewer team they engage with, understand what types of regulatory flexibility may be scientifically acceptable.” On a related webpage, the FDA outlines how it would flexibly interpret chemistry, manufacturing and controls requirements related to clinical development, commercialization and process validation. For example, the agency clarifies that there is no requirement for sponsors to supply three process performance qualification lots to validate their manufacturing process. [Read AgencyIQ deep dive here.] Apart from these new webpages, the FDA has not issued new guidance or other materials to further articulate this flexibility.

To contact the authors of this item, please email Alexander Gaffney ( agaffney@agencyiq.com), Amanda Conti ( aconti@agencyiq.com), Laura DiAngelo ( ldiangelo@agencyiq.com) and Ned Pagliarulo ( npagliarulo@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).