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American Journal of Law & Medicine

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https://www.readbyqxmd.com/read/30106661/expansion-of-the-priority-review-voucher-program-under-the-21-st-century-cures-act-implications-for-innovation-and-public-health
#1
Michael S Sinha, Nina Jain, Thomas Hwang, Aaron S Kesselheim
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106660/new-and-improved-21-st-century-cures-act-revisions-to-certificates-of-confidentiality
#2
Leslie E Wolf, Laura M Beskow
Certificates of Confidentiality ("Certificates") are a federal legal tool designed to protect sensitive, identifiable research data from compelled disclosure. Congress first authorized their use in 1970 to facilitate research on illegal drug use. The scope of their use was later expanded to cover mental health research and then again to apply broadly to identifiable, sensitive research data, regardless of topic. Certificates can be critical to enabling conduct of essential research on sensitive topics, such as effective interventions to curb the opioid epidemic or reduce HIV transmission among minority youth...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106659/off-label-marketing-s-audiences-the-21-st-century-cures-act-and-the-relaxation-of-standards-for-evidence-based-therapeutic-and-cost-comparative-claims
#3
Sam F Halabi
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106658/the-growing-importance-of-mental-health-parity
#4
Jessica A Scarbrough
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106657/the-evolution-of-federal-regulation-of-human-drugs-in-the-united-states-an-historical-essay
#5
Peter B Hutt
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106656/massachusetts-approves-mass-eye-ear-and-partners-healthcare-merger
#6
Kendahl L Melvin
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106655/the-21-st-century-cures-potpourri-was-it-worth-the-price
#7
Jerome P Kassirer
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106654/preface-the-21-st-century-cures-act-a-cure-for-the-21-st-century
#8
Andrea-Gale O Okoro
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106653/a-rat-by-another-name-21-st-century-cures-act-and-stem-cell-therapies
#9
Margaret F Riley
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106652/how-the-21-st-century-cures-act-can-mitigate-the-ever-growing-problem-of-mass-incarceration
#10
Jennifer S Bard
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106651/practice-based-research-networks-and-the-mandate-for-real-world-evidence
#11
Elizabeth Hall-Lipsy, Leila Barraza, Christopher Robertson
The 21st Century Cures Act encourages the Food and Drug Administration to consider "real-world evidence" in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106650/21-st-century-cures-for-the-opioid-crisis-promise-impact-and-missed-opportunities
#12
Leo Beletsky
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106649/real-world-data-analytics-fit-for-regulatory-decision-making
#13
Sebastian Schneeweiss, Robert J Glynn
Healthcare database analyses (claims, electronic health records) have been identified by various regulatory initiatives, including the 21st Century Cures Act and Prescription Drug User Fee Act ("PDUFA"), as useful supplements to randomized clinical trials to generate evidence on the effectiveness, harm, and value of medical products in routine care. Specific applications include accelerated drug approval pathways and secondary indications for approved medical products. Such real-world data ("RWD") analyses reflect how medical products impact health outside a highly controlled research environment...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106648/the-challenge-of-regulating-clinical-decision-support-software-after-21-st-century-cures
#14
Barbara Evans, Pilar Ossorio
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106647/real-world-evidence-in-the-real-world-beyond-the-fda
#15
Joan H Krause, Richard S Saver
The 21st Century Cures Act ("Cures Act") 1 relies on the concept of real-world evidence ("RWE") 2 to improve the Food and Drug Administration ("FDA") approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106646/21-st-century-cures-act-and-medical-device-regulation-departure-from-principles-or-catching-the-wave
#16
Eleanor D Kinney
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106645/fast-forward-to-the-frightening-future-how-the-21-st-century-cures-act-accelerates-technological-innovation%C3%A2-at-unknown-risk-to-us-all
#17
Anthony W Orlando, Arnold J Rosoff
No abstract text is available yet for this article.
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30106644/21-st-century-citizen-pharma-the-fda-patient-focused-product-development
#18
Jordan Paradise
Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/29764324/baby-m-turns-30-the-law-and-policy-of-surrogate-motherhood
#19
Eric A Feldman
This article marks the 30th anniversary of the Supreme Court of New Jersey's Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature. First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be taken to minimize the potential exploitation of women who are willing to rent their wombs for income? Third, what criteria should govern the eligibility to serve as a surrogate mother and an intended parent? Fourth, what principle(s) should serve as the basis for determining the parentage of children born through surrogacy? Fifth, is regulatory uniformity in the surrogacy realm desirable? Is it achievable? The article concludes that courts and legislatures should accept the validity of surrogacy contracts, determine parentage according to intent, and identify transparent criteria for the eligibility of both surrogates and intended parents...
March 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/29764323/swaps-and-chains-and-vouchers-oh-my-evaluating-how-saving-more-lives-impacts-the-equitable-allocation-of-live-donor-kidneys
#20
Evelyn M Tenenbaum
Live kidney donation involves a delicate balance between saving the most lives possible and maintaining a transplant system that is fair to the many thousands of patients on the transplant waiting list. Federal law and regulations require that kidney allocation be equitable, but the pressure to save patients subject to ever-lengthening waiting times for a transplant has been swinging the balance toward optimizing utility at the expense of justice. This article traces the progression of innovations created to make optimum use of a patient's own live donors...
March 2018: American Journal of Law & Medicine
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