FDA Scrutiny

Source: www.baltimoresun.com --- 13 days ago
Federal agency to look at effectiveness, safety of OTC products Federal regulators are planning to launch a broad new review of whether over-the-counter cold medicines are safe and effective for children under 12. ...

Source: highbloodpressure.about.com --- 66 days ago
In a front page story, the Wall Street Journal notes a major decline in the number of new drugs being produced by large pharmaceutical companies. Industry spokesmen confirm that... ...

Source: www.fiercepharma.com --- 65 days ago
What's a surefire way to win a contest? Keep your opponent from showing up, of course. That's what GlaxoSmithKline is trying to do  in the over-the-counter weight-loss market. The drugmaker has petitioned the FDA for more regulation of the supplements, namely, that any product making weight-loss claims should be subject to agency approval--or disapproval. Under current guidelines, diet pills don't have to undergo any clinical trials before they're let loose at a drugstore or supermarket near you. Of course, GSK's Alli product is a lower-dose version of the Roche med Xenical. It's the only FDA-approved diet drug sold over the counter. If the agency required all the others to submit to clinical trials, Alli would have the field to itself--unless and until other products' claims were substantiated by hard data. In its petition to the FDA, Glaxo brought the obesity epidemic to bear, saying that society can't afford to let overweight Americans rely on ineffective products. The American Dietetic Association and two other groups are backing GSK's bid. Predictably, trade associations for supplement makers are less than thrilled. The FDA and FTC already crack down on companies that make fraudulent or misleading weight-loss claims, they say. "It is already impermissible to sell snake oil," one supplement industry attorney told the Star-Ledger . But GSK is using the number of FTC crackdowns to bolster its case, saying that this proves consum ...

Source: www.asq.org --- 46 days ago
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Source: www.lawyersandsettlements.com --- 16 days ago
Washington, DC: A drug previously linked with acute pancreatitis is once again under Scrutiny by the US Food and Drug Administration (FDA) after reports continue to come in with regard to Byetta, the injectable medication from Amylin and Eli Lilly used as a treatment for Type 2 Diabetes. ...

Source: calorielab.com --- 24 days ago
Lowest levels of vitamin D led to increased deaths; Whole Foods to give beef more Scrutiny after recall; runners live longer than others; half of all overweight people deemed healthy; losing weight helps diabetics meet targets; and FDA says high fructose corn syrup can be natural. ...

Source: www.drug-injury.com --- 14 days ago
August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone (Posted by Tom Lamb at DrugInjuryWatch.com ) In a June 27, 2008 article, "Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices" , we said that soon after the July 4th Congressional recess there would be a bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) which would essentially correspond to HR 6381, the Medical Device Safety Act of 2008, introduced on June 26, 2008 by Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.). On August 1, 2008 the the Senate counterpart of the Medical Device Safety Act of 2008 was introduced on the Senate floor by Senator Patrick Leahy . The August 12, 2008 edition of FDAnews Device Daily Bulletin published an online report, "Senators Introduce Their Version of Anti-Preemption Bill" , which provides us with some context: Following the Riegel decision, Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, threatened to create legislation to override the court. He said Congress never intended for FDA approval to give immunity to manufacturers from liability for injuries caused by faulty devices. “The FDA used to be the gold standard, but the agency has come under Scrutiny recently. If manufacturers are putting faulty devices on the market, they must be held accountable ...

Source: lawprofessors.typepad.com --- 66 days ago
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Source: www.topix.com --- 45 days ago
3 Comments, last updated on Tuesday Jul 22 by Sebeth ...

Source: www.topix.com --- 55 days ago
National report - The ongoing Food and Drug Administration review of TNF-blocking biologic drugs is unlikely to have much impact on dermatologists' use of these drugs, physicians say. ...

Source: www.drugtopics.com --- 13 days ago
The FDA plans to mandate a stronger label for a diabetes drug marketed by Amylin Pharmaceuticals and Eli Lilly in the wake of deaths related to use of the drug. ...

Source: www.spendmatters.com --- 31 days ago
Spend management in the pharmaceutical sector has undergone some major changes in the past couple of years. As fewer block buster drugs come to market and pass FDA Scrutiny -- and as existing drugs come off patent -- a range of global pharma giants a... ...

Source: www.mpo-mag.com --- 52 days ago
Heightened Food and Drug Administration surveillance for problems with products already on the market could pressure medical-device makers by boosting research-and-development costs and the risk of negative news, according to Moody's Investors Service. Manufacturers of high-tech devices such as drug-coated stents - which are made by Boston Scientific Corp. (BSX), Johnson & Johnson (JNJ), Medtronic Inc. (MDT) and Abbott Laboratories (ABT) - appear to be most vulnerable to the increased Scrutiny, Moody's said in a recent report. The credit ratings firm examined the impact of an FDA plan announced in May, called "Sentinel", that aims to comb health databases from a variety of sources to identify product issues more quickly. "The increased Scrutiny could lead to greater volatility in sales and profitability, or even a prolonged downturn in credit fundamentals, for some medical device companies," Moody's said. The FDA's focus on so-called post-market studies, or often lengthy and costly studies that companies must perform once a new product is approved, will push up R&D costs for device makers over time, Moody's said. While the FDA's increased Scrutiny also affects drug makers, Moody's that that clinical trials for new drugs before and after approval already represent a large portion of development expenses. In the device sector, Moody's noted that the FDA has required long post-market studies of recently approved drug-coated stent heart dev ...

Source: healasthma.wordpress.com --- 29 days ago
What are available, so upset stomach, nausea, diarrhea; mouth and take SINGULAIR is delaying the launch of a therapy with insomnia. I just epilepsy, since March which are used for the most important Information before I am hoping the FDA Scrutiny is one 10-mg film-coated SINGULAIR without telling your pharmacist any unused portion. [...] ...

Source: library.pressdisplay.com --- 12 days ago
Federal regulators are planning to launch a broad new review of whether over-the-counter cold medicines are safe and effective for children under 12. The Food and Drug Administration said yesterday that it will hold public hearings on the medications... ...