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Nexstim Oy, a medical device company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Navigated Brain Stimulation System for use in the assessment of the primary motor cortex for pre-procedural planning. Full Article at News-Medical.net
On Wednesday, the Galen Institute held a session on the Value of Innovation in Healthcare. Full Article at The American | American Enterprise Institute
WASHINGTON - SEPTEMBER 29: Deputy commissioner of the Food and Drug Administration Jesse Goodman testifies before the House Oversight and Government Reform Committee September 29, 2009 in Washington, DC. View Photo »
Right now, less than 1 percent of the seafood that's imported into Louisiana is physically inspected by the Food and Drug Administration. We have to continue to tell people that we put together a safe, fresh product that's good to eat and safe to eat.
(IsraelNN.com) A northern Israeli biotechnology firm has just filed its New Drug Application with the U.S. Food and Drug Administration for an innovative new treatment for Gaucher's disease. Protalix Biotherapeutics Inc. Full Article at Arutz Sheva
By Anirban Chowdhury and Rumman Ahmed MUMBAI -- Ranbaxy Laboratories Ltd. will launch its generic version of the urinary disorders drug, Flomax, in the U.S. in March 2010, a top executive said Thursday, allowing the Indian drug maker take advantage of... Full Article at Wall Street Journal
"Because the comparison of HFCS and sucrose are so similar, particular on absorption by the body, it appears unlikely that HFCS contributes more to obesity or other conditions than sucrose." Full Article at TheAutoChannel.com
Michael Levy, director of the Food and Drug Administration's (FDA) division of new drugs and labeling compliance, testifies on Capitol Hill in Washington, Tuesday, Sept. 29, 2009, before a Senate Judiciary subcommittee hearing on dietary supplements. View Photo »
The United States has decided against using adjuvants because the Food and Drug Administration has not fully reviewed them. Officials worried that a new product would make people even more nervous about the inoculation.
Main Category: Public Health Also Included In: Regulatory Affairs / Drug Approvals Article Date: 10 Dec 2009 - 2:00 PST email to a friend printer friendly view / write opinions rate article RCT licensee Dyax Corp. has received approval from... Full Article at Medical News Today
There’s hope on the horizon for the 155,000 Brooklynites coping with diabetes, medical experts recently forecast. Full Article at New York Post
The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmeti... Full Article
Former FDA Commissioner David Kessler holds up a piece of carrot cake at a bakery near his home in San Francisco, Monday, April 20, 2009. Kessler has a new book out on addiction-like overeating.
View Photo »Former FDA Commissioner David Kessler poses at his home in San Francisco, Monday, April 20, 2009. Kessler has a new book out on addiction-like overeating. His research highlights a food industry-driven environment that hijacks people's brains with high-fat, high-sugar foods.
View Photo »Former FDA Commissioner David Kessler poses at his home in San Francisco, Monday, April 20, 2009. Kessler has a new book out on addiction-like overeating. His research highlights a food industry-driven environment that hijacks people's brains with high-fat, high-sugar foods.
View Photo »The FDA-cleared, clinically proven ThermaClear(R) Acne Clearing Device delivers a controlled, 2-second pulse of targeted heat directly to individual pimples. The patented Thermal Pulse Technology(TM) clears pimples often in as little as 24 hours.
View Photo »Former FDA Commissioner Joins Greenleaf Health LLC -- Dr. Andrew von Eschenbach, who resigned last month as FDA Commissioner, has joined Greenleaf Health, a regulatory consulting firm with offices in New York and Washington, DC.
View Photo »From left, Food and Drug Administration (FDA) Director of the Center for Food Safety and Applied Nutrition Dr. Stephen Sundlof,Regional FDA Director Michael Chappell, Georgia Department of Agriculture Consumer Protection Division Oscar Garrison, J. Leek Associates, Inc.
View Photo »Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote(R).
View Photo »St. Jude Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta(TM) surgical lead for neurostimulation therapy.
View Photo »St. Jude Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta(TM) surgical lead for neurostimulation therapy.
View Photo »From left, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention Director Dr. Anne Schuchat; Assistant Health and Human Services Secretary for Preparedness and Response Dr. Nicole Lurie; and Food and Drug Administration Acting Chief Scient...
View Photo »Food and Drug Administration Acting Chief Scientist Dr. Jesse Goodman, right, accompanied by Assistant Health and Humans Services Secretary for Preparedness and Response Dr. Nicole Lurie, testifies on Capitol Hill in Washington, Wednesday, Nov. 18, 2009, before the joint House Health an...
View Photo »Assistant Health and Humans Services Secretary for Preparedness and Response Dr. Nicole Lurie, left, accompanied by Food and Drug Administration Acting Chief Scientist Dr. Jesse Goodman, testifies on Capitol Hill in Washington, Wednesday, Nov. 18, 2009, before the joint House Health and...
View Photo »St. Jude Medical, Inc. announced today that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon(TM) neurostimulator, a rechargeable device used to help manage chronic pain.
View Photo »Cell Culture Manager Sanaz Arenivas lifts a rack containing vials of frozen cells used for cloning cattle and other livestock from a liquid nitrogen vapor tank in a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »Embryo culture plates sit inside an incubator inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »Cell culture manager Sanaz Arenivas displays cells used for cloning cattle and other livestock inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »Embryologist Fernando Arenivas (L) and Director of Assisted Reproductive Technologies Shu-hung Chen work on the second step of the cloning process called reconstruction where a cell is inserted inside a membrane at ViaGen in Austin, Texas November 11, 2009.
View Photo »A shock of electro-fusion is used to make a cell fuse with the cytoplasm of an egg inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »Embryologist Fernando Arenivas gives cells a shock of electrofusion, which allows the cell to fuse with the cytoplasm of the egg, inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »An embryologist prepares cells for reconstruction inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »Frozen cells used for cloning cattle and other livestock are stored inside a freezer at ViaGen in Austin, Texas November 11, 2009. ViaGen, along with its partner company, Trans Ova Genetics of Sioux Center, Iowa, produces the vast majority of the clones in the United States.
View Photo »The calf Elvis is pictured in this undated photograph released on November 12, 2009. Animal cloning and genomics services company ViaGen produced Elvis in 2005 by cloning a Prime Yield Grade 1 Angus crossbred steer using a cell taken from its carcass.
View Photo »A dish of cells that have fused with the cytoplasm of an egg are seen inside a cloning lab at ViaGen in Austin, Texas November 11, 2009.
View Photo »K.C. , the first animal produced by cloning from a cell taken from a carcass, is pictured in this undated photograph released by animal cloning and genomics services company ViaGen on November 12, 2009.
View Photo »Farm workers Ricardo Visconti (L) and Ruben Perez hold Jersey transgenic cows, four-year-old Pampa Victoria and two-year-old Pampa Argentina respectively, in Buenos Aires in this April 17, 2007 file photo.
View Photo »Former FDA Commissioner David Kessler poses at his home in San Francisco, Monday, April 20, 2009. Kessler has a new book out on addiction-like overeating. His research highlights a food industry-driven environment that hijacks people's brains with high-fat, high-sugar foods.
View Photo »We've applied to the FDA (Food and Drug Administration) - we're jumping through hoops to make it happen. We think by the end of 2010 we'll be doing the first human patients
The manufacturer, Original Rangoon of Massachusetts, is in the process of reporting the matter to the U.S. Food and Drug Administration as the investigation continues
The H1N1 vaccination has been deemed to be safe by the U.S. Food and Drug Administration and the Centers for Disease Control [and Prevention] ... A pandemic flu is much more dangerous to our society as a whole than the vaccination.
A total number of 2,770 capsules were sold within 24 days of its private distribution. The monthly update of the same will be submitted for scrutiny to the Pune division of Food and Drug Administration in the next few days
This additional funding will help us continue the development of an obesity therapeutic into pilot manufacturing and preclinical studies in preparation for an Investigational New Drug filing with the U.S. Food and Drug Administration ... In our work to date, the candidate therapeutic has consistently de...
We are very encouraged by the results of this early-stage study and plan to move forward with additional animal studies and present the results to the U.S. Food and Drug Administration, in anticipation of human clinical studies ... We believe that the human eye represents an ideal point of access for th...
In addition, there is no known mechanism for microwave energy within the limits established by the [U.S. Federal Communications Commission] to cause any adverse health effects ... That is why the leading global heath organizations such as the American Cancer Society, [U.S.] National Cancer Institute, Wo...
You have to set up a quality system. We're regulated by the FDA (U.S. Food and Drug Administration).
The Food and Drug Administration is perhaps the most important health agency that we have in the United States of America, and probably in the world. The Centers for Disease Control may be a close-to-second. Obviously, NIH has an extraordinary role to play. But the Food and Drug Administration … has suc...
It is important for individuals to understand that there are two options available for vaccination against H1N1 ... The nasal mist, which is a weakened vaccine virus, and the injection, a killed vaccine virus, cannot cause the flu. Both are Food and Drug Administration approved in conjunction with the C...
We made substantial progress toward a definitive agreement with a lead potential partner; however, as the discussions progressed, we came to believe that it would be more productive to complete a partnership after we have received a response from the United States Food and Drug Administration, or FDA, r...
This grant provides significant non-dilutive resources for us to begin manufacturing LightTouch devices and disposables for an international launch, as we simultaneously complete the U.S. Food and Drug Administration (FDA) pre-market approval (PMA) application process
We look forward to discussing with the Food and Drug Administration a potential phase III registration strategy for this indication
but I am optimistic that eventually it will lead to something ... Even now, a US company, Geron, has received permission from the Food and Drug Administration to treat a spinal disease with embryonic stem cells.
We then asked the Pimpri-Chinchwad Chemists' Association to submit names of chemists having the Food and Drug Administration (FDA) licence to sell schedule X drugs
We did find out also that the FDA [Food and Drug Administration] conducted an audit of the facility in earlier in 2008, before my clients were notified-- and determined the STD [Sexually Transmitted Disease] screening that's required to be performed on the embryos, as a matter of federal law, was not ap...
You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' Tylenol liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA).
We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways.
The acquisition of Gigamoto enhances and accelerates our technology platform to include more top notch FDA approved technology solutions for complex post-approval programs.
While many labs may offer ways to test for gluten sensitivity, none of the tests offered (I repeat: none) has had any validation or FDA approval
Our polymer heart valve has been tested extensively and has satisfied FDA pre-requisites for human use
Oracle, the FDA, GS1, and Loftware: Improving Supply Chain Safety and Standards
As a partner with MedAssets for 8 years, we are excited to continue our collaboration to help hospitals reduce medical errors through positive identification, while streamlining and simplifying operations ... We're proud that our products meet the rigorous requirements of MedAssets to help customers mee...
As we are sure you understand, FDA has limited resources to sample every product or even every new product marketed in the United States to determine the accuracy of the nutrition labeling
The technique is known as 'SILS-Port, a US FDA-approved technique, which was introduced in India a fortnight back
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