Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices

Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices

Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). High intakes of the omega-6 (n-6) polyunsaturated fatty acids (PUFAs), linoleic acid (LA) and arachidonic acid (AA) may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A) both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B) the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity.</p> <p>Methods</p> <p>Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks.</p> <p>Results</p> <p>Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/(NCT01157208)">(NCT01157208)</a></p

Comparative Biochemistry, Biodegradability, and Toxicity of DDT and Carbofuran Analogues

Project B-070-ILL, Matching Grant Agreement No. 14-31-0001-3879; Water Resources Center Research Report 95, Final ReportReport issued on: December 1974Prepared for unspecified recipien

Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices

Data from: Newly recognized Famennian lungfishes from East Greenland reveal tooth plate diversity and blur the Devonian–Carboniferous boundary

Three specimens of lungfishes from the late Famennian of East Greenland are described. One forms the holotype of a new genus and species, Celsiodon ahlberg gen. et sp. nov., which, in cladistic analyses, is placed close to the Carboniferous genus Ctenodus. The analyses reveal some Late Devonian lungfishes clustering with Early Carboniferous taxa, suggesting that Late Devonian lungfishes included more crownward taxa than previously appreciated, and that the Devonian-Carboniferous boundary was more fluid for lungfish taxa than supposed. Further study of other specimens shows a range of tooth plate morphologies and tooth crown morphologies, suggesting that the Late Devonian lungfishes were even more diverse and occupied a wider range of feeding strategies than previously suspected