What a new FDA commissioner could mean for clinical research

With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials. During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels and banning menthol in cigarettes. He also oversaw the approval of a record number of new medicines, generic drugs and medical devices. Yet his departure leaves many questions unanswered, especially those that impact the medical device industry. Here are just a few of them. What will become of the 510(k) program? In November 2018, in a joint statement with Dr. Jeffrey Shuren, the director of the Center for Devices and Radiological Health, Dr. Gottlieb announced that the FDA would be proposing certain changes to the 510(k) program for approving medical devices. The current 510(k) program has been in place since the 1976 Medical Device Amendments and allows devices to be considered for approval if they are “substantially equivalent” to previously approved devices. The FDA has made a number of changes to this program in recent years, including: Increasing premarket expectations for 510(k) submissions Implementing a policy refusing to accept incomplete submissions Moving toward eliminating the use of the 510(k) programs for Class III medic...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news

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Momentum is growing for a nationwide movement to raise the legal age of tobacco purchase from 18 to 21. Experts say the widespread and worrisome teen vaping epidemic is a major catalyst—but so is support from e-cigarette and tobacco companies, which has some health groups feeling uneasy. On June 7, Texas joined about a dozen other states in enacting so-called Tobacco 21 policies; even more cities and counties have raised their legal buying ages, and a string of national retailers have instituted corporate policies that echo these legislative efforts. In Texas, the law will raise the purchasing age for all tobacco pro...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized public health Source Type: news
It’s a Wednesday evening in Brooklyn, NY, and bars are dead. Tea-candle-dotted tables sit empty, waiting for a happy hour rush that isn’t. But tucked away on a side street, hours before its midnight closing time, a bar called Getaway hums with activity. Metal straws clink against ice and cocktail shakers rattle as patrons belly up to the marble bar. A woman fresh out of work reads and nurses a drink at a corner table. An early-thirties couple chats over a pre-dinner beverage, holding hands in the flattering dim lighting. This is New York City’s first permanent booze-free bar, and no one is drinking alcoho...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized public health Source Type: news
After a two-year wait, the Food and Drug Administration (FDA) on Tuesday green-lit the sale of a new gadget that heats tobacco instead of burning it. The device, which is called IQOS (pronounced EYE-kose) and made by Philip Morris International, works by heating tobacco-filled sticks, called Heatsticks, to produce a nicotine-rich aerosol. The FDA’s decision means the device may now be marketed in the U.S. — but even though IQOS has been shown to produce fewer of the cancer-causing chemicals found in traditional cigarettes, the FDA has not yet approved a separate application to call IQOS a lower-risk alternative...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized public health Source Type: news
Shervi Lie1†, Elise Rochet1†, Erik Segerdell2, Yuefang Ma1, Liam M. Ashander1, Audra M. A. Shadforth3,4, Timothy A. Blenkinsop5, Michael Z. Michael6, Binoy Appukuttan1,6, Beth Wilmot2 and Justine R. Smith1,6* 1Eye and Vision Health, Flinders University College of Medicine and Public Health, Adelaide, SA, Australia 2Department of Biostatistics, Oregon Health and Sciences University, Portland, OR, United States 3Queensland Eye Institute, Brisbane, QLD, Australia 4School of Biomedical Science, Queensland University of Technology, Brisbane, QLD, Australia 5Departments of Cell, Developmental and Regener...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
This study included 18 buffy coats collected from volunteer blood donors admitted to the blood transfusion service of IRCCS Bambino Gesù Pediatric Hospital after obtaining informed consent. The Ethical Committee of IRCCS Bambino Gesù Pediatric Hospital approved the study (825/2014) and conducted in accordance with the ethical principles stated in the Declaration of Helsinki. Cells Lines and Cell Culture NK-92 (malignant non-Hodgkin's lymphoma), K562 (chronic myelogenous leukemia, CD19−), Jurkat (acute T cell leukemia, CD19−) Karpas 299 (Human Non-Hodgkin's Ki-positive Large Cell ...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
Juul founders Adam Bowen and James Monsees, who were named to the 2019 TIME 100 list, called vaping’s potential for helping adult smokers ditch combustible cigarettes “one of the greatest opportunities for public health in the history of mankind” at the TIME 100 Gala on Tuesday. Juul has dominated the e-cigarette market with its sleek devices, which deliver nicotine without many of the harmful, cancer-causing substances in combustible cigarettes. But while the devices are designed to give adult smokers an alternative to cigarettes, Juul and other brands have developed a massive following among teenagers &...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized onetime public health T100 2019 TIME 100 Source Type: news
Parents of a Florida teenager who became addicted to Juul havesued Juul, Altria, and Philip Morris USA based on a number of claims, including fraud, negligence, and violation of the RICO statute (the compliant ishere). Dr. Stan Glantz and Lauren Lempert provide a nicesummary of the reasoning behind the lawsuit and the specific claims being made. The case was filed on Monday in the federal district court for the middle district of Florida.The Rest of the StoryAlthough the main complaint is that the company fraudulently provided misinformation about the product, its health risks, and its addictiveness, the complaint itself p...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs
ConclusionsThe two generalized designs (the two-facet unbalanced design and the one-facet multivariate design) indicated that the effects of the participate and the effects associated with the participate accounted for the majority of the total variation of the MPATS for Chinese college students, and the test items were not the main source of measurement errors. According to the generalizability coefficient and dependability index, the MPATS can be used either as a Norm Referenced Test or as a Criterion Referenced Test, but it depends on the research intention of the study that uses this scale. For the specific dimensions ...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Ryan R. Kelly1,2†, Lindsay T. McDonald1,2†, Nathaniel R. Jensen1,2, Sara J. Sidles1,2 and Amanda C. LaRue1,2* 1Research Services, Ralph H. Johnson VA Medical Center, Charleston, SC, United States 2Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC, United States The significant biochemical and physiological effects of psychological stress are beginning to be recognized as exacerbating common diseases, including osteoporosis. This review discusses the current evidence for psychological stress-associated mental health disorders as risk factors for os...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
In one of his last acts as head of the Food and Drug Administration (FDA), outgoing Commissioner Dr. Scott Gottlieb released new plans for restricting the sale of certain flavored e-cigarettes, in an effort to combat teen vaping. The draft guidance, which will remain open for public comment for 30 days before being finalized, crystallizes some of the agency’s prior plans for regulating flavored e-cigarettes, which have become so popular among teenagers that many doctors fear they could contribute to widespread nicotine addiction among young people. Vaping among high school students rose by 78% (from almost 12% to alm...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized public health Source Type: news
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