Yale CRRIT
@yalecrrit.bsky.social
The Collaboration for Regulatory Rigor, Integrity, & Transparency (CRRIT), based out of Yale Medical, Public Health, & Law schools, researches the regulation, approval, & coverage of medical drugs & devices to advance policies that improve patient health.
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:
December 22, 2025 at 3:44 PM
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)
December 19, 2025 at 5:04 PM
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)
Reposted by Yale CRRIT
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)
December 8, 2025 at 10:52 PM
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...
www.nejm.org
December 8, 2025 at 5:00 PM
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)
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.
December 4, 2025 at 4:29 PM
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)
November 18, 2025 at 9:18 PM
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)
November 11, 2025 at 5:25 PM
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)
November 4, 2025 at 2:05 PM
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)
November 3, 2025 at 6:35 PM
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
November 1, 2025 at 11:15 PM
“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)
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)
October 24, 2025 at 1:57 PM
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)
October 10, 2025 at 9:36 PM
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)
@yaleschoolofmed.bsky.social/@yalesom.bsky.social/ @cspinet.org study examining IV hydration spa regulation & practices (1/3)
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)
October 7, 2025 at 8:05 PM
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)
@yaleschoolofmed.bsky.social/@yalesom.bsky.social/ @cspinet.org study examining IV hydration spa regulation & practices (1/3)
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)
October 7, 2025 at 2:37 PM
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)
September 30, 2025 at 7:52 PM
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)
September 26, 2025 at 8:28 PM
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)
September 25, 2025 at 5:01 PM
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)
Reposted by Yale CRRIT
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/healthaffair...
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,
academic.oup.com
September 20, 2025 at 12:14 PM
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/healthaffair...
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)
September 18, 2025 at 4:41 PM
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)
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)
September 10, 2025 at 2:13 PM
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)
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)
September 2, 2025 at 9:28 PM
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)
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)
August 15, 2025 at 3:21 PM
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)
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)
August 7, 2025 at 6:00 PM
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)