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)

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)

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)

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)

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)

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

Yale CRRIT@yalecrrit.bsky.social · 5mo ago

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)

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)

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)

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)

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)

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

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)

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

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:

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)

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)

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)

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...

nejm.org

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.

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)

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)

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)

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)

“In considering the future of biotech, one thing has become clear: new biotechnology discoveries will be of no use to my patients or any patients if they are unable to afford them." x.com/P4ADNOW/stat... (1/5)

Patients For Affordable Drugs NOW on X: "Rather than strengthening Medicare negotiation, bills have passed to further exempt or delay negotiation for even more drugs approved for rare diseases. For example, price negotiations for Jakafi, approved for rare bone marrow cancer and other non-rare blood conditions, are https://t.co/yOP1atoEZS" / X

Rather than strengthening Medicare negotiation, bills have passed to further exempt or delay negotiation for even more drugs approved for rare diseases. For example, price negotiations for Jakafi, approved for rare bone marrow cancer and other non-rare blood conditions, are https://t.co/yOP1atoEZS

x.com

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)

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)

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)

Yale CRRIT@yalecrrit.bsky.social · 10mo ago

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)

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)

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)

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)

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)