Tag Archives | FDA

Mercury Poisoning Linked To Skin Products

FDA says that many anti-aging, smoothing, skin-lightening, and beauty lotions and creams sold at ethnic beauty shops and online have dangerous levels of Mercury. Mercury Poisoning Linked to Skin Products View more documents from Law Offices of Sadaka Associates LLC.

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FAQ Friday #1 – FDA’s Role In Drug Approval

What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of [...]

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Top Five News Stories Of The Week For December 16, 2011

Another week in the bank.  Here are my picks for the top five stories of the week: Hospitals Adopt Drug Industry Sales Strategy.  Hospitals are starting to sell themselves using ole’ pharma tactics! Plaintiffs Win Key Ruling On Preemption In Metoclopramide Mass Tort Litigation.  A state trial judge in Philadelphia has denied generic drug manufacturers’ [...]

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Medical Device Manufacturer Caught Red Handed, Patients Still Lose

Bottom-line: Medtronic pays doctors to recommend defective devices. Once those defective devices hurt the patient that patient cannot sue the manufacturer. Medtronic Inc. agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to [...]

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Pay For Positive Results, Money Talks Science Walks

Bottom-Line: Clinical Trial’s Funded By Big Pharma Are More Likely To Provide Positive Results The primary role of the FDA in the drug approval process is to simply review the results of clinical trials. Since the FDA does not perform clinical trials, it must largely rely on data from clinical trials organized and paid for [...]

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FDA Panel Wants More Risk Information On Yaz Pills

Bayer’s Yaz, Yasmin contraceptive products will stay on the market. However, the FDA panel reviewing the products want more information about the possible increased risk of blood clots. What happens now? The advisory committee made their recommendation but the final approval of the new labeling comes from the FDA itself. We will have to wait [...]

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Agency Overrules FDA’s Recommendation That The Morning After Bill Be Available Without A Prescription

In a move that smacks of politics rather than safety, the Department of Health and Human Services overruled the FDA’s decision to make the “morning after pill” or Plan B available over the counter. The sign that this move is more political than safety related, the Secretary of DHHS issued a statement containing the following: [...]

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Sadaka’s Science Tips: The Role Of The FDA

What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of [...]

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Medical Devices Unnecessarily Implanted Causing Injury And Death

In a study published in the January 2011 issue of the Journal of the American Medical Association, researchers scrutinized the use of implantable cardioverter-defibrillators (ICD) in 111,000 recipients to analyze whether or not they met the appropriate criteria for placement of one of these devices. In this study, researchers found that an overwhelming 22.5% of [...]

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FDA Cops To Get Act Together

Bottom-Line: FDA cops operate with little accountability to the FDA…let alone the American people. Evil doers beware. The cops at the FDA are getting better organized and more cash to chase executives who seek to do harm to the public’s health. Cops at the FDA you ask? Why yes there are cops at the FDA. [...]

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