Posts Tagged "fda"

FDA: Your Own Cells Are a Drug

Posted on Jan 13, 2016 in News, Political

To protect Big Pharma, the FDA is coming after stem cell therapies. Don’t let the agency classify your body as a pharmaceutical drug. Action Alert! In the next few months, the FDA will hold a public meeting to discuss its recent actions to clamp down on the use of autologous stem cell treatments. This is when a doctor removes adult stem cells from a patient, processes them, and returns the cells to the same patient. The public meeting will discuss four guidance documents the agency has released over the last two years (here, here, here, and here). They are meant to clarify which treatments...

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Tonsillectomy for Sleep Apnea Carries Risks for Some Kids: Study

Posted on Nov 19, 2015 in Medical Rewind

Though the surgery is a primary treatment for sleep disorder, breathing problems can occur afterwards. MONDAY, Sept. 21, 2015 (HealthDay News) — Children who have their tonsils removed to treat sleep apnea are more likely to suffer breathing complications than kids who have the procedure for other reasons, a new review shows. Researchers found that across 23 studies, about 9 percent of children undergoing a tonsillectomy developed breathing problems during or soon after the procedure. But the risk was nearly five times higher for kids with sleep apnea, versus other children. Experts...

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‘Breakthrough’ drug may not mean what you think

Posted on Nov 18, 2015 in Medical Rewind

(Reuters Health) – What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims. As the researchers on the new study describe it, the FDA Safety and Innovation Act, passed in 2012, allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that “may demonstrate a...

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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

Posted on Nov 18, 2015 in News, Vaccines

FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women Vaccine manufacturers and federal health officials want to fast track to licensure new experimental vaccines targeting pregnant women with the goal of preventing certain kinds of infections in newborn infants. On Nov. 13, 2015, the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) convened a one day public meeting at the FDA headquarters in Silver Spring, MD to discuss proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy.   NVIC representatives attending the...

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Polio vaccines causing worldwide surge in childhood paralysis cases

Posted on Nov 17, 2015 in Medical Rewind, Vaccines

In April 2012, Aaron Dykes of Truthstream Media reported that statistically speaking, polio had been eradicated in India, but the statistics don’t tell the whole story. In fact, he noted, there was a spike in “non-polio acute flaccid paralysis (NPAFP) – the very types of crippling problems it was hoped would disappear with polio but which have instead flourished from a new cause.” How could that happen in a nation where polio had ostensibly been eradicated? Quite simply, Dykes noted, the new spike was actually coming from the oral polio vaccine. He further reported:...

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