CRISPR People: The Science and Ethics of Editing Humans, Book Talk with...
On February 17, 2021, the Center for Law & the Biosciences sponsored a book talk on CRISPR People: The Science and Ethics of Editing Humans with book author and Director of the CLB, Professor Hank...
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Safeguards for accelerated market authorization of vaccines in Europe
People around the globe are concerned about safety issues encircling the accelerated introduction of corona vaccines. In this article, we discuss the regulatory safeguards for fast-track market...
View ArticleLunch talk on “Regulatory Trends in the Personalization and Consumerization...
On May 20th, the Center for Law and the Biosciences hosted a lunch talk by Vinita Kailasanath (JD ’10) and Mahnu Davar, partners at Arnold & Porter, on “Regulatory Trends in the Personalization and...
View ArticleReflections on Bioprinting Law: How Should 3D-Bioprinted Organs Be...
Over the past few decades, the medical field has been revolutionized by new developments in science and technology. One important innovative technology that is likely to be a game-changer in the...
View ArticleDmitry Karshtedt—A Memorium
I was and am heartsick to hear of Dmitry Karshtedt’s death earlier this week, and it’s hard being composed while reading the fields of tributes pouring in about Dmitry and his incredible life. Bob...
View ArticleFDA pathway for wearable medical devices
While sitting down reading a book on the early afternoon of July 15, 2022, Nancie got an “alarming” message on her Apple Watch SE: “Your heart rate fell below 40 BPM for 10 min.” Despite feeling...
View ArticleNew complaint shows potential trouble for companies selling wearable pulse...
In a blog last month, I wrote about wearable medical devices and FDA law. I discussed how companies like Apple and Fitbit have applied for FDA clearance under 510(k) to produce and sell wearables that...
View ArticleGender Norms Perpetuated by Differences in Egg and Sperm Donation Processes
Many women between the ages of 20 and 30 see frequent targeted advertisements on social media advertising for fertility clinics and the opportunity to make substantial money (often $10-$100,000) for...
View ArticleSpillover Risk in Environmental Impact Assessment: Preventing the Next Pandemic?
Ragini Gupta, LLM student We think of the HIV/AIDS epidemic as having begun around the 1980s, which is when the CDC first reported symptoms of a deadly pneumonia in clusters of previously healthy...
View ArticlePGT-A under the Spotlight
The birth of the first in vitro fertilization (“IVF”) baby, Louise Brown, in 1978 gave hope to thousands of people suffering from infertility. Since then, new technologies have been developed as...
View ArticleHeteronormativity in Gamete Donation Has Far-Reaching Legal Ramifications
Assisted reproductive technology (ART) is a class of fertility treatments that help people who want to be parents have kids of their own, as an alternative to adoption, and usually with at least one...
View ArticlePotential Pandemic Pathogens – Risks, Regulation and Reform: Part I
Ragini Gupta, LLM expected 2023 Where might the next epidemic disease come from? It might, like AIDS or Ebola, jump to humans from a natural reservoir. It might also come from a laboratory. While this...
View ArticlePotential Pandemic Pathogens – Risks, Regulation and Reform: Part II
Ragini Gupta, LLM expected 2023 In Part I of this post, I discussed the law and policies governing a subset of life science research involving ‘potential pandemic pathogens’ (PPPs). This legal...
View ArticleScientific Potential of Assisted Reproductive Technology for Homosexual...
My last blog post focused on existing assisted reproductive technology (ART) and how societal and legal heteronormativity harms queer couples trying to grow their families. I recommended that men who...
View ArticleUnlocking Scientific Innovation Through Decentralized Science – Part I
The last decade has been marked by exponential technological advancement in distributed ledger technology and blockchain. Blockchain is mostly associated with cryptocurrencies, however, more non-crypto...
View ArticleUnlocking Scientific Innovation Through Decentralized Science – Part II
In Part I of this blog post I provided an overview of blockchain, DeSci, and the current funding problems that science as an institution is experiencing. In Part II I will discuss how DeSci can address...
View ArticleThe New Kid on the Block: Prescription Video Games, Part II
In Part I of this blog post I provided an overview of the first prescription video game, EndeavorRx, that has been cleared by the FDA for treating attention deficit hyperactivity disorder (“ADHD”)...
View ArticleThe New Kid on the Block: Prescription Video Games, Part I
Picture a world where parents no longer scold their kids for playing video games due to their perceived negative effects, but instead, actively encourage their kids to play their video game because it...
View ArticleA Legal and Ethical Perspective on Human Consciousness and Human Brain Organoids
Since Professor Shinya Yamanaka’s discovery of reprogramming mature human cells into human induced pluripotent stem cells (“iPSCs”) for which he received the Nobel Prize in 2012, human iPSCs have...
View ArticleAvailability of virtual prescribing to decrease access barriers for drugs on...
In 2007, Congress expanded the FDA’s post approval authority with the Food and Drug Administration Amendments Act. Specifically, the act allowed the FDA to institute Risk Evaluation and Mitigation...
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