WASHINGTON: ‘ FDA Top Official Under-Fire to Resign Over Drug Abuse Scandal ‘

#AceWorldNews – WASHINGTON – September 24 – Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency’s policies have contributed to a national epidemic of prescription painkiller abuse.

' Zohydro FDA Approved Against Medical Advice '

‘ Zohydro FDA Approved Against Medical Advice ‘

In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009.

The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

#ANS2014

#fda, #obama, #washington, #zohydro

‘ Toxic Practise FDA Allows Despite Health Risks ‘

#AceNewsServices – September 21 – This toxic practice makes seriously decayed meat look fresh for weeks and is banned in many countries including the European Union and Japan.

' Toxic Meat Being Sold As Fresh '

‘ Toxic Meat Being Sold As Fresh ‘

Many consumers are unaware that over 70% of beef and chicken in the United States and Canada is treated with poisonous carbon monoxide gas and the FDA allows it, despite the known public health risks.

A bill was introduced in Congress that would require the labelling of meat that has been treated with carbon monoxide but it was never enacted and the topic was swept under the rug entirely. [Bill: H.R. 3115 (110th) introduced on July 19, 2007; never enacted.]

This practice makes meat appear and smell fresh even when contaminated with harmful bacteria such as Clostridium botulinum, Salmonella, Campylobacter, and E-coli 0157:H7.

Carbon monoxide makes meat appear fresher than it really is by reacting with the meat pigment myoglobin to create carboxymyoglobin.

This bright red pigment masks the natural tell tale signs of spoiled meat such as rank odours and slime.

Meats containing carboxymyoglobin will appear red and fresh for days or even weeks beyond the point of spoiling.

Read More:Source: 

#ANS2014

#congress, #fda, #united-nations, #united-states

‘ FDA New Rules for Prevention of Food Contamination ‘

#AceNewsServices – WASHINGTON – September 21 – Seemingly regular cycle of food contamination scares about various food processing facilities prompted Congress to require revisions to Food and Drug Administration food safety regulations.

On September 19 the FDA offered an early look at proposed rules on produce safety and preventive controls in human food production, plus preventive controls in animal food production and on foreign supplier verification programs.

A comment period on the rule proposals will begin after they are officially published in the Federal Register on Sept. 29.

CQ Roll Call’s Georgina Gustin reports that the new rules are designed to make the inspection process less burdensome, especially for small and organic food growers, as the agency is dropping a nine-month delay on developing risk analysis on manure and eases restrictions on the agricultural water quality standards.

The proposed rule for produce products also clarifies what constitutes a covered farm, saying that those with produce sales – not food sales – under $25,000 annually will not be subject to the rules.

Additionally, the revised regulations on preventive controls for animal food addresses concerns raised by brewers and livestock farmers, that unprocessed spent grains – a by-product of the brewing process – would be not be subject to new regulations when sold as animal feed.

The proposed rules on foreign supplier verification requires annual on site auditing of foreign suppliers, but companies with well-documented supply chains could opt out.

#ANS2014 

#animal-food, #congress, #fda, #washington

` FDA has granted approval to ` Pluristem Therapeutics ‘ to mass produce `Human Placenta Derived Stem Cell Products ‘

#AceHealthNews – ISRAEL – 23 March – The US Food and Drug Administration has granted approval http://www.pharmabiz.com/NewsDetails.aspx?aid=80807&sid=2to Pluristem Therapeutics to mass produce therapeutic human-placenta-derived stem cell products within its commercial-scale manufacturing facility in Haifa, Israel.

Pluristem’s Placental Expanded (PLX) products are mesenchymal-like adherent stromal cells – connective tissue cells in an organ – from human placentas, which are lush with hormones and proteins. The FDA has cleared PLX for use in studies on treating injuries, one step closer to full approval of PLX cells in treatments.

PLX products are made via Pluristem’s “automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment.”

“The PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an ‘off-the-shelf’ product that requires no tissue matching prior to administration,” according to Pluristem.

Pluristem operates out of a high-output facility in northern Israel that can produce about 150,000 doses of PLX products a year. http://on.rt.com/j7qdeo

From the CEO – http://www.pluristem.com/

Our vision at Pluristem Therapeutics inc. is to leverage our position as the global leader in placenta-based cell science to become the world’s leader in developing and manufacturing cell therapy products.

We believe our cutting edge technology can become the standard of care for treating a host of inflammatory and ischemic conditions.

We are in the process of achieving this vision by building a successful, winning team to maintain our standard of excellence in the research, development and production of cell therapies.

We continue to develop our understanding surrounding the mechanism of action of PLacental eXpanded (PLX) cells. We then leverage this understanding towards the development of these cells for additional markets. Currently we are actively pursuing indications in the peripheral vascular, pulmonary, orthopedic, ob-gyn and hematology markets.

We also believe “the Process is the Product.” This reflects our view that the precise control of the entire process, from obtaining cells from the source, to delivery to the patient, is vitally important to the success of a cell therapy product. Part of the reason we are able to obtain this precision in our cell expansion process is our exclusive ability to expand cells via our proprietary 3D technology.

Combining this “Powered by Pluristem” fully automated process with our increasing knowledge of the placental cell is the powerful engine towards identifying additional products for new markets and indications.

Every engine needs a driver, which returns me to the key to success for achieving our vision: the team. Our team has the ability, integrity, commitment and courage to develop breakthrough cell therapies that can transform the treatment of certain diseases and deliver value to our shareholders.
Zami Aberman
Chairman and CEO

#ANS2014

#fda, #federal-drug-administration-fda, #pluristem, #pluristem-therapeutics-incorporated

` Doctors are Warning of a `Brand New’ recently FDA-Approved `Pain-Killer’ `Zohydro’ is Deadly Dangerous’

#AceHealthNews says according to latest news from RT a new painkiller set to hit the market in March is coming under heavy fire from doctors and lawmakers warning of its powerful ability to kill.

Although the opiate Zohydro was ultimately approved by the US Food and Drug administration, that endorsement went against the recommendation given by the agency’s own advisory panel.

The panel voted 11 – 2 against approving the drug, but the FDA argued its availability is necessary to help patients un-fazed by current medication.

The new drug has not become available yet, but a group of more than 40 doctors is hoping to pre-empt its release by urging the FDA to reconsider its decision.

According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths.

The doctors warned that the drug could potentially kill an individual after taking only two Zohydro capsules.

A child, meanwhile, could suffer a fatal overdose from just one pill.

#ANS2014 & RT

#fda, #rt-news, #zohydro

#AceNewsServices says according to BI and Bloomberg they…

#AceNewsServices says according to BI and Bloomberg they have reported that Google X, the cordoned-off branch of Google that’s spawned stuff like Google Glass and the driver-less car, is now meeting with the FDA to discuss medical devices.

The whispered theory here is that there may be bio-sensors in Google Glass that will listen to your body and provide feedback to the device.

The meeting included at least four Google workers, some of whom have connections with Google X — and have done research on sensors, including contact lenses that help wearers monitor their biological data. Google staff met with those at the Food and Drug Administration who regulate eye devices and diagnostics for heart conditions, according to the agency’s public calendar.

More Soon ……………………………………………………………………………………………

#bloomberg-television, #fda, #google, #google-glass

IF: You Want People To Keep Raising Tax Dollars by Smoking – Let the FDA Regulate E-Cigarettes

#AceWorldNews says In 2010, the FDA determined that certain e-cigs were unapproved pharmaceutical products and detained or refused imports from some manufacturers. One manufacturer fought back, and a federal court held that e-cigs are not pharmaceutical products but that the FDA could regulate them as tobacco products.

“It seems pretty clear that the FDA will regulate electronic cigarettes like tobacco products,” said Theodore L. Wagener, an assistant professor at the University of Oklahoma Health Sciences Center who’s researching the products.

Regulating the cigarette look-a-likes as tobacco products would make them subject to the age, marketing and packaging restrictions that apply to traditional cigarettes. It might prohibit sales to minors, ban advertising on television and require warning labels on packaging.

The White House is reviewing a proposal from the FDA; the process might last 90 days or more.

Meanwhile, the debate about the potential benefits and risks of e-cigs has escalated.

Advocates promote the products as healthier alternatives to cigarettes that give users their nicotine fixes without the toxins and carcinogens generated by burning tobacco. Some advocates also say e-cigs might help smokers quit.

But critics say e-cigs may increase nicotine addiction and tobacco use among young people; they also point out that the FDA says not enough research has been done for consumers to know whether e-cigs are safe or harmful.

While the price of cigarettes has continuously increased since 1965, the percentage of that price going towards taxes is now half of what it was then.[19] While tobacco companies complain about the $1.01 cigarette tax, Phillip Morris, Reynolds American, and Lorillard have all increased their prices by almost $1.00 per pack on their own. Phillip Morris currently lists all taxes, including federal, state, local, and sales taxes, as 56.6% of the total cost of a pack of cigarettes.

READ MORE:

http://www.mcclatchydc.com/2013/11/26/209666/as-feds-ponder-future-of-e-cigarettes.html#emlnl=Morning_Newsletter

This transmission is intended for the named addressee(s) only and may contain sensitive or protectively marked material up to RESTRICTED and should be handled accordingly. Unless you are the named addressee (or authorised to receive it for the addressee) you may not copy or use it, or disclose it to anyone else. If you have received this transmission in error please notify the sender immediately.

#e-cigarettes, #fda, #lorillard, #phillip-morris, #taxes, #tobacco, #white-house