A Is In Your Tomato Sauce The Food and Drug Administration finally came out with their long-awaited update on the use of Bisphenol A in food contact applications and they say.......wait a little longer. The key paragraph of the release can use some... Full Article at Treehugger
Filipino demonstrators dressed as pregnant women wearing mock beauty products on their head walk during a rally in Manila's Chinatown district of Binondo, Philippines on Sunday March 7, 2010. In their statement, the Ecowaste Coalition said 12... View Photo »
WASHINGTON - FEBRUARY 03: Sen. John McCain (R-AZ) (R) speaks about dietary supplements while flanked by Rob Manfred (L) executive vice president of labor for Major League Baseball,Kicker Vencill (2nd-L) former U.S. Swim Team member, Jeremy Bloom... View Photo »
On March 18, 2010, the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance. “In 2009, we focused on seeking regulatory... Full Article at Freshnews.com
DIEGO -- (BUSINESS WIRE) -- Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by... Full Article at Freshnews.com
WSJ.com is available in the following editions and languages: Thank you for registering. We sent an email to: Please click on the link inside the email to complete your registration Please register to gain free access to WSJ tools. An account already... Full Article at Wall Street Journal
Dennis Balint, CEO of the California Walnut Commission, said growers and packers should expect increased oversight by the federal government on food safety issues and traceability. We can expect intense scrutiny, he said. There have been surprise [Food... Full Article at Delta Farm Press
Today Katie McQue Please Login to read the full article. Shares in the US company MannKind dropped by 25% earlier this week as investors reacted to a US FDA complete response letter for its inhaled rapid-acting insulin product... Full Article at Scrip News
BioSante's lead products include LibiGel(R) (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction... Full Article at Trading Markets
US FDA Staff Says Novartis AG and Astellas Pharma Inc. 3/18/2010 Reuters -- Novartis AG (NOVN.VX) (NVS.N) and Astellas Pharma (4503.T) eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in... Full Article at Biospace
PMX-30063, PolyMedix’s antibiotic compound is a small molecule that mimics human host-defense proteins and has a completely different mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial... Full Article at Freshnews.com
March 18 /PRNewswire/ -- Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for... Full Article at RedOrbit
AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday. Agency scientists said 46... Full Article at The Post Chronicle
There are currently no results.
We look forward to working closely with the FDA as review of the Esbriet NDA continues.
FDA stresses that it is everyone's responsibility in the supply chain to look closely, to care about the quality of the products they sell ... If there is not a solid market for these stolen goods, the thieves will do something else.
By working together, CPTR partners can take years off the drug development timeline for safer new TB drug regimens ... The commitments of FDA and regulators in Europe helping to develop new and improved testing methods, and of companies making their compounds and expertise available, show leadership and...
With its leadership on TB, FDA is poised to repeat its creative regulatory approach to AIDS drugs in the 1990s, which helped save the lives of millions without compromising drug quality ... It's encouraging that drug companies, FDA, the Gates Foundation and partners are all collaborating to speed faster...
With its leadership on TB, FDA is poised to repeat its creative regulatory approach to AIDS drugs in the 1990s, which helped save the lives of millions without compromising drug quality ... It's encouraging that drug companies, FDA, the Gates Foundation and partners are all collaborating to speed faster...
FDA is absolutely committed to working with partners to speed access to new, safe and highly-effective treatments for TB, which continues to mutate and spread ... I've seen first hand the public health impact and personal tragedy of drug-resistant TB. This creative approach mirrors FDA's own investments...
FDA is absolutely committed to working with partners to speed access to new, safe and highly-effective treatments for TB, which continues to mutate and spread ... I've seen first hand the public health impact and personal tragedy of drug-resistant TB. This creative approach mirrors FDA's own investments...
You've got the salami scare, and it may be the peppers in the salami (that are contaminated), but USDA does the salami and FDA does the peppers
We will work closely with the FDA to address the conditions of approval proposed by the FDA panel so that we can make this therapy available to patients with epilepsy who have limited treatment options.
The task force is developing recommendations for making information about FDA activities and decisions more useful, understandable and readily available, while appropriately protecting confidential information
We also recently announced the filing of an IND with the FDA for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF) which is the most deadly disease of the lungs in humans and for which there is currently no proven effective treatment. We expect to start a Phase I clinical t...
The U.S. pharmaceutical distribution system is tightly controlled and monitored, making it extremely difficult for stolen product to make it to patients through legitimate channels. However, we will continue to work closely with local and federal law enforcement authorities, the FDA, and our distributio...
The fact that we now have our own treatment planning system with FDA clearance is a milestone of strategic importance
ClinAudits’ experience in auditing for compliance with FDA regulations, International Congress on Harmonization (ICH) Guidelines, and local governmental regulatory guidelines will be highly beneficial to the BQSI Expert Working Group.
This latest patent issuance is a clear sign that the company is continuing to make very good progress toward FDA approval and commercialization of an important product.
Developing individualized medicines needs a solution bigger than any one group can generate. The Biomarkers Consortium is a public-private collaboration of scores of organizations working together to achieve this critical mission. It is a model for the future and FDA is proud to be a founding member.
We are really looking forward to getting guidance from the FDA
Some in the clinical and patient communities ... have challenged FDA to require tighter performance standards
It’s important to note that their [2004] FDA approval came before the information about the potential cancer risks occurred…The question of whether those are reasonable risks to express to people is part of what the IRB would have to decide. Without an IRB, I’m guessing they would never be mentioned.
To conduct [a study] without independent review is not right — it may place people who have volunteered their time at risk… In terms of regulation, the device is not approved for this use, it falls under FDA regulation, and it requires independent review by an IRB.
Big Pharma is often the focus of the attacks about industry funding, but the accusations don’t stop with that industry ... Even the Obama FDA was criticized for using industry-funded science in their BPA decision, and now it’s coming around to the AHA as well. They do receive industry support, and there...
If marriage were a drug, the FDA would not approve it
The FDA again issued a letter 10 days later telling us to manufacture it because customers were getting affected
Given Boston Scientific's conservative actions, the FDA seems unlikely to take punitive actions
We are working closely with the FDA to resolve the situation as soon as possible.
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Food and Drug Administration tips on using flea and tick spot-on products here: http://bit.ly/cMGHqf
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