Filtered By:
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of relevance.

Order by Relevance | Date

Total 5166 results found since Jan 2013.

Nutritional Supplements for the Treatment and Prevention of Sports-Related Concussion-Evidence Still Lacking.
Abstract Concussions are common neurologic events that affect many athletes. Very little has been studied on the treatment of concussions with supplements and medications. The U.S. Food and Drug Administration (FDA) reminds us that no supplement has been proven to treat concussions. Many animal studies show that supplements have potential for improving the effects of a brain injury but none have been shown to be of consistent benefit in human studies. Animal studies on severe traumatic brain injury (TBI) may not therefore be applicable transfer to sports-related concussions (SRC).Of the many supplements reviewed i...
Source: Current Sports Medicine Reports - July 1, 2017 Category: Sports Medicine Authors: Trojian TH, Wang DH, Leddy JJ Tags: Curr Sports Med Rep Source Type: research

Current Insights into the Potential Misuse of Platelet-based Applications for Doping in Sports
Int J Sports Med DOI: 10.1055/a-0884-0734Platelet-based applications are currently used for the delivery of growth factors and other biomolecules as autologous biomaterials in regenerative medicine and cosmetic therapies. Many studies have revealed that platelet-based applications such as platelet-rich plasma and platelet releasate exhibit beneficial biological effects after a sports injury or trauma when administered locally by intramuscular injections. At present, treatment of the public, patients and athletes with platelet-based applications is permitted and regulated by the Food and Drug Administration and the World An...
Source: International Journal of Sports Medicine - April 22, 2019 Category: Sports Medicine Authors: Scully, David Matsakas, Antonios Tags: Review Source Type: research

FDA Regulation of Adult Stem Cell Therapies as Used in Sports Medicine
This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.[...]Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.Article in Thieme eJournals:T...
Source: Journal of Knee Surgery - January 20, 2015 Category: Orthopaedics Authors: Chirba, Mary AnnSweetapple, BerkleyHannon, Charles P.Anderson, John A. Tags: Special Focus Section Source Type: research

Nutritional Supplements for the Treatment and Prevention of Sports-Related Concussion—Evidence Still Lacking
Concussions are common neurologic events that affect many athletes. Very little has been studied on the treatment of concussions with supplements and medications. The U.S. Food and Drug Administration (FDA) reminds us that no supplement has been proven to treat concussions. Many animal studies show that supplements have potential for improving the effects of a brain injury but none have been shown to be of consistent benefit in human studies. Animal studies on severe traumatic brain injury (TBI) may not therefore be applicable transfer to sports-related concussions (SRC). Of the many supplements reviewed in this article, ...
Source: Current Sports Medicine Reports - July 1, 2017 Category: Sports Medicine Tags: Nutrition and Ergogenic Aids: Section Article Source Type: research

Essential Features of Third-Party Certification Programs for Dietary Supplements: A Consensus Statement.
This article puts forward the consensus of the authors on current best practices for third-party certification programs for dietary supplements consumed by athletes and military service members. Also discussed are important ways that third-party programs can develop in the future to improve access to safe, high-quality dietary supplements for these populations. PMID: 31082891 [PubMed - in process]
Source: Current Sports Medicine Reports - April 30, 2019 Category: Sports Medicine Authors: Eichner AK, Coyles J, Fedoruk M, Maxey TD, Lenaghan RA, Novitzky J, Lindsey AT, Deuster PA Tags: Curr Sports Med Rep Source Type: research

UofL Health's chief of sports medicine charged in federal court
Dr. Lonnie Douglas, the chief of sports medicine for UofL Health Inc., has been charged in federal court for his part in an alleged conspiracy to bring human growth hormone from China to the United States. Documents from the U.S. District Court for the Western District of Kentucky state that the Food and Drug Administration investigated Douglas’ alleged violation of the Food, Drug, and Cosmetic Act — which prohibits the distribution or possession with the intent to distribute the drug for anythi ng…
Source: bizjournals.com Health Care:Biotechnology headlines - February 19, 2021 Category: Biotechnology Authors: Chris Larson Source Type: news

Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine
This article provides an overview of the efforts of the U.S. Food and Drug Administration (FDA) to facilitate product development in the field commonly known was regenerative medicine. It provides an introduction to the processes by which FDA works with individual sponsors, interacts with the scientific and industry communities, participates in standards development, and develops formal FDA policy and guidance.
Source: Stem Cells Translational Medicine - December 10, 2015 Category: Stem Cells Authors: Witten, C. M., McFarland, R. D., Simek, S. L. Tags: Concise Review, Tissue Engineering and Regenerative Medicine Source Type: research

FDA Announces Recall Of Another Heart Medicine For Possible Cancer Risk
(CNN) — The US Food and Drug Administration is alerting patients of another recall of medicine used to treat high blood pressure, for a potential cancer risk due to contamination. This time, SciGen is recalling certain lots of irbesartan. The recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, according to the FDA list. Another heart medicine, valsartan, has also been recalled recently due to contamination. Irbesartan is an angiotensin II receptor blocker, or ARB. This is a drug that blocks a potent chemical in the blood called anigiotensin, which causes muscles ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 1, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Local TV Recall Source Type: news

Marijuana-Based Medicine To Reduce Seizures Gets Positive FDA Review
WASHINGTON (AP) — A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday. British drugmaker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis — one that doesn’t get users high — as a medication for rare, hard-to-treat seizures in children. If successful, the company’s liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S. The Food and Drug Administration’s approval wou...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 17, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Cannabidiol Epidiolex Local TV Marijuana Oil Source Type: news

‘Bionic Pancreas’ For Diabetics Developed At MGH, BU
Scientists have made big progress on a “bionic pancreas” to free some people with diabetes from the daily ordeal of managing their disease. A wearable, experimental device passed a real-world test, constantly monitoring blood sugar and automatically giving insulin or a sugar-boosting drug as needed, doctors said Sunday. The device improved blood-sugar control more than standard monitors and insulin pumps did when tested for five days on 20 adults and 32 teens. Unlike other artificial pancreases in development that just correct high blood sugar, this one also can fix too-low sugar, mimicking what a natural pancr...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - June 16, 2014 Category: Consumer Health News Authors: miketoole Tags: Health Local News bionic pancreas Boston University CBS Boston Diabetes Massachusetts General Hospital New England Journal Of Medicine WBZ Source Type: news

‘Bionic Pancreas’ For Diabetics Developed At MGH, BU Makes Progress
BOSTON (CBS/AP) – Last fall, WBZ introduced you to the “bionic pancreas”, and now new research published in the New England Journal of Medicine shows it can do what it was designed to do. Ed Damiano is an Assistant Professor of Biomedical Engineering at Boston University. He has spent years worrying about his 15-year-old son, David, who has Type 1 Diabetes, and sometimes develops low blood sugar at night, which can be deadly. “He sleeps through any particular disturbance you can muster, including low blood sugar,” says Damiano. So he and a colleague developed the “bionic pancreas”,...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - June 16, 2014 Category: Consumer Health News Authors: miketoole Tags: Health Local News Seen On WBZ-TV Watch Listen bionic pancreas Boston University CBS Boston Diabetes Dr. Mallika Marshall Massachusetts General Hospital New England Journal Of Medicine Source Type: news

US Definitions, Current Use, and FDA Stance on Use of Platelet-Rich Plasma in Sports Medicine
J Knee SurgDOI: 10.1055/s-0034-1390030With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP a...
Source: Journal of Knee Surgery - September 30, 2014 Category: Orthopaedics Authors: Beitzel, KnutAllen, DonaldApostolakos, JohnRussell, Ryan P.McCarthy, Mary BethGallo, Gregory J.Cote, Mark P.Mazzocca, Augustus D. Tags: Special Focus Section Source Type: research

Cardiac Arrest in a 21-Year-Old Man After Ingestion of 1,3-DMAA–Containing Workout Supplement
We describe a case of a young man who took such a supplement and suffered a cardiac arrest. Notably, the product consumed was not on the FDA list of substances containing DMAA. This case highlights the importance for clinicians to be aware of the potential harm of the DMAA-containing products by maintaining a high index of suspicion in otherwise healthy individuals presenting with cardiac arrest. It is of particular importance to sports medicine physicians who are most involved in education and counseling of patients potentially at risk of taking such products.
Source: Clinical Journal of Sport Medicine - December 31, 2014 Category: Sports Medicine Tags: Case Report Source Type: research

Mesothelioma Patients Benefit from Integrative Medicine Expert
Dr. Ka-Kit Hui is no expert on mesothelioma cancer, but he helps mesothelioma patients live longer and better lives every day. Committed to teaching the benefits of integrative medicine, Hui’s vision blends the best of traditional Chinese and conventional Western medicines, skillfully bridging the gap between the two. He launched the UCLA Center for East-West Medicine in 1993 — one of the first integrative medicine centers in the U.S. — leading it to national prominence. Clinically proven to improve health and healing, its programs often increase survival time. “Our hope is to do things that improve the quality o...
Source: Asbestos and Mesothelioma News - January 12, 2017 Category: Environmental Health Authors: Walter Pacheco Tags: doctor ka-kit hui at ucla east west medicine integrative medicine for mesothelioma international symposium on malignant mesothelioma mesothelioma research Source Type: news

Alternative Medicine Alone Leads to Lower Cancer Survival
Cancer patients who opt for alternative therapy instead of conventional medicine significantly decrease their chances of survival, according to researchers at Yale School of Medicine. Although the popularity of alternative medicine continues to grow, a recent study published in the Journal of the National Cancer Institute found survival rates significantly reduced for those who use it as first-line therapy. Conventional cancer treatments — chemotherapy, surgery and radiation — still produce a much better chance of survival. Mesothelioma was not included in the study, but the findings are relevant to this rare and aggr...
Source: Asbestos and Mesothelioma News - August 23, 2017 Category: Environmental Health Authors: Matt Mauney Tags: acupuncture cancer Alternative medicine alternative mesothelioma treatment alternative therapy survival alternative vs conventional medicine breast cancer colon cancer Conventional cancer treatments Dr. David Gorski Dr. Skyler Johnson Source Type: news