FDA Advisory Panel Says New HPV Test Better for Cervical Cancer Screening
An FDA advisory panel voted unanimously this week that a new HPV test could be used before or instead of the Pap smear as a first step in cervical cancer screening. In three separate 13-0 votes, the agency’s Medical Devices Advisory Committee Microbiology Panel concluded that the cobas HPV (human papillomavirus) test, made by Roche […]
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FDA Commissioner Defends New Pain Drug
FDA Commissioner Margaret Hamburg this week defended FDA’s approval of Zohydro, which is a powerful opioid that is made by Zogenix. She noted that it offers a unique chance to treat pain, even with serious concerns about abuse. FDA’s approval of this new drug has drawn a lot of flak, including from the attorneys general […]
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Will OTC Lipitor Win FDA Approval?
Lipitor, which is the biggest selling drug ever with more than $13 billion in sales at its peak in 2006, is very well known for its ability to lower LDL cholesterol levels. It has been studied in many randomized clinical trials with thousands of patients for years. These studies have show how important this drug […]
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FDA Overhauls Drug Approval Path for OTC Drugs
FDA announced last week that it is going to overhaul how it approves OTC medical products. There is no doubt that this is going to make big changes to how thousands of drugs and personal care items are going to get to stores in the US. The products that will have the approval process changed […]
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FDA Chief Says Indian Drugmakers Must Improve cGMP Quality
Indian companies, which supply about 25% of all of the drugs that are used in the United States, have to take more responsibility for quality control as they export their products to foreign markets, according to FDA’s commissioner Margaret Hamburg. She also noted that FDA is going to ramp up cGMP audits in India. Her […]
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FDA Is Refusing to Allow Ranbaxy Labs to Export from Banned Factories
FDA this week denied the request from Ranbaxy Laboratories to allow the drugmaker to continue to export its products from banned manufacturing plants, as they continue to take remedial actions to fix the GMP problems in the plants. This request was made by the managing director Arun Sawhney at a big meeting with CEOs of […]
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FDA Seeks More Information on Female Libodo Drug
Sprout Pharmaceuticals, a pharma company that has been working on a drug to increase libido in women, has been asked to provide more clinical studies to FDA. FDA wants to see more information on how the drug – flibanserin – interacts with other drugs and how it affects one’s ability to drive. About 10% of […]
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How Effective Are FDA Approvals?
FDA is effectively the gatekeeper in the US for access to many types of pharmaceuticals. That is why it gets so much attention from the media, as well as from Congress. Some will say that FDA is too lenient in making drug approvals, and that it subjects people to unproven drugs. But others say FDA […]
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FDA Investigating Risks of Testosterone Therapy
FDA announced at the end of last week that it is going to investigate risks of heart disease and death that may be caused in some cases by testosterone therapy. This is a move by FDA that is being prompted by two clinical studies that have raised some questions about the health risks of using […]
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FDA – Aleve Safer For Heart Than Other Drugs
FDA state this week that the Aleve pain reliever could be safer for your heart than many other types of anti-inflammatory drugs that millions of Americans take every day. According to an FDA review that was posted on the FDA website this week, naproxen could have a lower heart attack risk as well as stroke, […]
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