iiinova — where your digital self keeps evolving

Yale CRRIT @yalecrrit.bsky.social · 04/09/2026

In February 2026, former FDA leadership announced via journal publication a consequential shift away from basing drug approval on two or more clinical trials to just one. (1/6)

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Yale CRRIT @yalecrrit.bsky.social · 06/07/2026

Now out in @jama.com is our new secret shopper study characterizing how patients experience online prescribing of GLP-1 receptor agonists from telehealth platforms (1/13)

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Yale CRRIT @yalecrrit.bsky.social · 02/07/2026

We are excited to share a new article in @jamanetworkopen.com Open that investigated internet searches for leucovorin, folate, and acetaminophen following a widely watched and misleading White House press conference on autism last Fall (1/6)

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Yale CRRIT @yalecrrit.bsky.social · 23/04/2026

Surrogate endpoints are widely used in clinical trials because they can make studies faster and more cost-effective. However, these indirect measures do not always capture clinically significant outcomes that reflect how patients feel, function, or survive (1/7)

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Yale CRRIT @yalecrrit.bsky.social · 20/04/2026

We are excited to share a recently published article in @jamahealthforum.com evaluating the FDA’s Sentinel Initiative and its Active Risk Identification and Analysis (ARIA) system for postmarket drug safety surveillance, a key tool used by FDA to protect patients and public health (1/9)

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Yale CRRIT @yalecrrit.bsky.social · 01/04/2026

Over the past decade, with growth across the internet and social media, there has been corresponding growth in the spread of misinformation, including on issues related to health. Prior research has shown that websites that post misinformation are often motivated by advertising revenue (1/5)

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Yale CRRIT @yalecrrit.bsky.social · 25/03/2026

Between 2000-2025, pharmaceutical manufacturers penalized for kickbacks paid only 2.2% of US revenue accrued from selling implicated drugs (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 13/03/2026

We are excited to share a recently published article in @jamanetworkopen.com examining 25 years of kickback-related settlements between the U.S. government and pharmaceutical manufacturers (1/4)

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Yale CRRIT @yalecrrit.bsky.social · 26/01/2026

We are excited to share Part 1 of our Health Affairs article on the promises & concerns of @fda.gov’s new ‘Plausible Mechanism’ pathway, announced in Nov 2025 in a manner that deviated from the proper, transparent legal process FDA is required to follow (1/5)

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Yale CRRIT @yalecrrit.bsky.social · 22/01/2026

We are excited to share a recently published editorial in @jama.com that discusses the FDA’s review of REMS requirements for mifepristone. (1/7)

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Yale CRRIT @yalecrrit.bsky.social · 21/01/2026

We are excited to share a recently published article in @journalgim.bsky.social which investigates the level of evidence and strength recommendations of US Medical Society clinical practice guidelines (1/5)

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Yale CRRIT @yalecrrit.bsky.social · 20/01/2026

There have been significant changes at @fda.gov including “ultra-accelerated” reviews. (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 19/01/2026

In September, the @fda.gov announced draft guidance on safety labeling changes (SLCs) under section 505(o)(4) of the FD&C Act. (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 09/01/2026

While @fda.gov typically engages with the public & convenes advisory committees for expert advice, this has happened less in the past year. (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 22/12/2025

On Friday, @fda.gov announced 2 more drugs awarded Commissioner National Priority Vouchers. But as @lizzylawrence.bsky.social @statnews.com laid out, political interference has clouded this program, raising questions on the scientific integrity & rigor of FDA's drug review:

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Yale CRRIT @yalecrrit.bsky.social · 19/12/2025

CRRIT Co-Director @jsross119.bsky.social was recently asked by @medshadow.bsky.social about @fda.gov's new policy to reduce the number of clinical trials required for new drug approvals, allowing the pharmaceutical industry to submit data from only one pivotal trial (1/5)

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Reposted by Yale CRRIT

Joseph Ross @jsross119.bsky.social · 08/12/2025

New paper from @yalecrrit.bsky.social out today in @jamainternalmed.com - The 2007 US Food and Drug Administration (FDA) Amendments Act (FDAAA) expanded the agency's safety-related regulatory authorities, including enhanced postmarketing safety surveillance and new clinical study requirements (1/5)

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Yale CRRIT @yalecrrit.bsky.social · 08/12/2025

Now out in @nejm.org is a new Perspective piece from the CRRIT team on the potential consequences of @fda.gov's recent announcement to release daily drug adverse event reports from FDA’s Adverse Event Reporting System (FAERS) www.nejm.org/doi/full/10.... (1/11)

nejm.org

Enhancing FDA Drug-Safety Surveillance — Beyond Releasing Daily Adverse-Event Data | NEJM

The FDA recently announced that it will be releasing daily drug adverse-event data. But questions remain about how it will manage frequent releases and how the public may interpret released informa...

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Yale CRRIT @yalecrrit.bsky.social · 04/12/2025

ICYMI: @lizzylawrence.bsky.social in @statnews.com News scooped that the @fda.gov is planning to require only a single pivotal clinical trial to be the basis of drug approval, rather than 2 or more.

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Yale CRRIT @yalecrrit.bsky.social · 18/11/2025

We are excited to share our first CRRIT newsletter! Our quarterly newsletter will share recently published research, CRRIT mentions in the news, conferences and meetings, and policy engagement (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 11/11/2025

We’re excited to share a recently published article in @jamainternalmed.com, led by Emory Medical School student Ravi Dhawan investigating venture capital (VC) investing trends by academic medical centers (AMCs). (1/7)

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Yale CRRIT @yalecrrit.bsky.social · 04/11/2025

The White House recently announced a draft framework that will ease the path for the @fda.gov to approve biosimilars. Comparative efficacy studies will not necessarily be required, which in turn will result in earlier market entry (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 03/11/2025

We are excited to share a recently published article in Clinical Trials which investigated confirmatory evidence supporting single pivotal trials for new drug approvals. (1/8)

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Yale CRRIT @yalecrrit.bsky.social · 24/10/2025

We are excited to share a recently published article in Journal of Pharmaceutical Policy and Practice, which investigated the therapeutic benefits of the most expensive drugs covered by Medicare and Medicaid (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 10/10/2025

We are excited to share a recently published article in @jhppl.bsky.social which investigates the past, present, and future of @fda.gov reforms. As numerous changes occurring at the agency threaten public trust and scientific rigor, there is still opportunity to reenvision the future (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 07/10/2025

Great news segment by @nbcnews.com of our CRRIT/ @yaleschoolofmed.bsky.social/@yalesom.bsky.social/ @cspinet.org study examining IV hydration spa regulation & practices (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 07/10/2025

We are excited to share a recently published study in @jamainternalmed.com which investigates state-level policies related to intravenous (IV) hydration spa regulation. Information regarding the safety of IV spas is limited (1/5)

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Yale CRRIT @yalecrrit.bsky.social · 30/09/2025

We are excited to share a recently published article in @nature.com Medicine, which investigates the decision-making process of individual officials when disagreements occur @fda.gov over drug approvals & ways to increase transparency (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 26/09/2025

Despite an unproven link between the use of Tylenol during pregnancy and autism, the @fda.gov has initiated a label change process for acetaminophen products. It is expected that the manufacturer, Kenvue Inc, will challenge this as they stated there is no proven link. (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 25/09/2025

A significant number of companies have created large businesses selling GLP-1 compounded products. The @fda.gov recently sent 50 warning letters to these companies regarding false and misleading claims about compounded drugs (1/4)

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Reposted by Yale CRRIT

Holly Fernandez Lynch @hollylynchez.bsky.social · 20/09/2025

Here's our new article reporting findings from stakeholder interviews in which we hoped to learn what it takes to successfully complete rigorous confirmatory studies after accelerated approval. Instead, we mostly heard willingness to trade rigor for feasibility. 1/ academic.oup.com/healthaffair...

academic.oup.com

Flexibility Over Rigor: Stakeholder Acceptance of the Limitations of Confirmatory Studies Following Accelerated Approval

Despite the importance of postmarketing requirements (PMRs) following accelerated approval and well-recognized shortcomings in their rigor and timeliness,

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Yale CRRIT @yalecrrit.bsky.social · 18/09/2025

For decades @fda.gov has convened advisory committees of outside experts to discuss and vote on individual drug applications FDA CDER Director recently indicated that FDA intends to move away from these drug-specific advisory committees (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 10/09/2025

We are excited to share a recently published article in @ Journal of the National Cancer Institute which measured industry payments for oncology drugs that received accelerated approval before and after negative confirmatory trial findings (1/4)

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Yale CRRIT @yalecrrit.bsky.social · 02/09/2025

We are excited to share a recently published study in @jamahealthforum.com , determining whether the lack of clinical validation and publicly traded company status were associated with recalls of AI-enabled medical devices (AIMDs). (1/4)

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Yale CRRIT @yalecrrit.bsky.social · 25/08/2025

User fees have had a critical role in funding the @fda.gov since the enactment of PDUFA. A new RAPS article quoted our recent @nejm.org perspective “Reforming the Prescription Drug User Fee Program” (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 16/08/2025

User fees have had a critical role in funding @fda.gov since 1992. In our new @nejm.org Perspective, we outline the history and intent of PDUFA, & suggest potential reforms to the PDUFA VIII negotiation process to enable transparency & promote patient-centeredness (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 15/08/2025

An increasing number of cancer drugs and gene therapies are receiving accelerated approval from @fda.gov. However, increased use of accelerated approval pathways raises concerns surrounding safety, efficacy, and clinical benefit (1/3)

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Yale CRRIT @yalecrrit.bsky.social · 07/08/2025

ICMYI: AI/ML-enabled medical devices have potential for earlier diagnosis & symptom monitoring for Alzheimer’s disease & other dementias. A new @jama.com current study led by @hopkinsmedicine.bsky.social student Krista Chen looks at demographic representativeness of these devices (1/4)

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Yale CRRIT @yalecrrit.bsky.social · 01/08/2025

Many older adults have obesity, yet few were included in clinical trials for GLP1s. Study exclusion criteria (depression, prior cancer) may contribute to the under-enrollment of adults ≥ 65 years (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 30/07/2025

Biosimilars provide low-cost options for patients and expanded access to treatment, but use of these treatments is hampered by @fda.gov requirements for interchangeability (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 29/07/2025

Many clinicians do not recommend compounded GLP-1RAs and are uninformed when patients seek these medications, which can leave patients vulnerable to misinformation. (1/2)

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Yale CRRIT @yalecrrit.bsky.social · 21/07/2025

High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.

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Yale CRRIT @yalecrrit.bsky.social · 15/07/2025

ICYMI: @fda.gov released a limited set of denial letters for drugs that were ultimately approved. CRRIT Co-Director @jsross119.bsky.social recently told @nytimes.com why these letters are important (1/2) 🔗 www.nytimes.com/2025/07/10/h...

nytimes.com

F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs

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Yale CRRIT @yalecrrit.bsky.social · 15/07/2025

CRRIT Co-Director @reshmagar.bsky.social provided public comments at the Prescription Drug User Fee Act (PDUFA) VIII Kickoff Meeting @fda.gov yesterday. Dr. Ramachandran discussed how the user fee process could be reformed to be more patient-centered & transparent.

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Yale CRRIT @yalecrrit.bsky.social · 20/06/2025

The @fda.gov says it will “radically increase efficiency” with AI and embrace “radical transparency.” But as @reshmagar.bsky.social told @nytimes.com, agency officials recently kicked off a six-city listening tour—with Pharma CEOs—behind closed doors. Here’s the scoop:

nytimes.com

F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’

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Yale CRRIT @yalecrrit.bsky.social · 02/06/2025

Do companies continue promoting drugs granted @fda.gov accelerated approval even after failed confirmatory trials? Yes—though less aggressively, finds Dr. Maryam Mooghali’s #ASCO25 Merit Award-winning research. 🔗 meetings.asco.org/abstracts-pr...

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Yale CRRIT @yalecrrit.bsky.social · 22/05/2025

For patients with rare diseases, high-quality health info can be scarce. Research led by CRRIT post-doc Mengyuan Fu, PhD, on @nordrare.bsky.social’s free online disease reports found that 50% of sources cited were unavailable online or behind paywalls (~$168 per report). But... 🧵

jamanetwork.com

Access to Information Cited in National Organization for Rare Disorders Reports

This cross-sectional study describes the availability and access cost to the public of research findings and other clinical insights relevant to rare diseases.

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Reposted by Yale CRRIT

NCSP at Yale @ncspyale.bsky.social · 14/05/2025

Congrats to Reshma Ramachandran MD, MPP, MHS (Yale NCSP '20–'22), winner of the 2025 Bernard Lown Award for Social Responsibility! 👏 A powerful voice for health equity. Learn More: bit.ly/reshma-lown2025 #HealthEquity #SocialResponsibility #YaleNCSP #PharmaReform #PublicHealth@reshmagar.bsky.social

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