FDA Making Changes to Drug and Manufacturing Oversight
FDA Commissioner Margaret Hamburg, MD, is seeking new ways for the agency to deal with its complex regulatory roles, especially as it pertains to drugs. In 2013, Hamburg came up with a new agency wide organization to make key recommendations to improve how FDA centers deal with its audit employees. The result of that effort [...]
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FDA Studies Drug Inspections Using Drone Technology
FDA is looking into the use of airborne drones to help it to conduct cGMP inspections of drug and device facilities. There is not any formal drone program in place or being developed, FDA is looking at the feasibility of using drones for certain drug inspection applications. If FDA decides to use drones for FDA [...]
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FDA Warning Letter Hits Sun Pharma for Hiding Batch Failures
A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn’t hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash. [...]
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FDA Slams US Wockhardt Plant With 483
FDA issued a Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wochardt’s drugmaking facility in Morton Grove, Illinois, over seventeen days between January and March, according to a document on the agency’s website. Two of the Mumbai-based drugmaker’s Indian facilities are already banned from exporting to the U.S. after [...]
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FDA Hits Wockhardt US Plant for Using Same Bad Tests as In India
FDA has lashed out at India’s Wockhardt, saying a plant in the U.S. was using the same questionable drug-testing procedures that led the agency to ban two of Wockhardt’s Indian plants last year. The observation is one of a dozen cited in a Form 483 the FDA has issued to Wockhardt’s Morton Grove Pharmaceuticals plant, [...]
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FDA Must Act on Sunscreen Ingredients
Those feel like you’re getting sunburned quicker or more often than in years past, those people are probably right. The sun is getting stronger, but the protection offered by our sunscreens in the U.S. isn’t keeping up. It’s been 15 years since the FDA approved new ingredients for use in sunscreens. With one person dying [...]
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FDA Warning Slapped on Sun Lamps and Tanning Beds
FDA has issued a final decision to reclassify sunlamp products and ultraviolet or UV lamps used in indoor tanning salons. The federal agency has changed the labeling requirements from low-risk to moderate-risk devices. They are also requiring the products carry a black box, visible to consumers, that states the products should not be used on [...]
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FDA OK’s Drugs That Boost Heart and Stroke Risks?
FDA is coming under fire after it approved many drugs that predictably increase heart and stroke risk. The editorial by Robert P. Blankfield, MD, MS, a clinical professor of family medicine, notes that several medications survived FDA scrutiny, only to be pulled from the market after reports of increased heart attacks and strokes related to [...]
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Hamburg: Drugs Can Get to Patients Faster and Cheaper
A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, FDA’s commissioner noted this week. The program, approved in 2012, can cut the time needed for approval by years, a gain for companies that may be reflected in pricing, said Food [...]
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Sun Pharma Ripped by FDA in Warning Letter
FDA has given generics maker Sun Pharmaceutical an earful, and publication of its seven-page May 7 Warning Letter—which characterizes the list of infractions as “not intended to be an all-inclusive list of violations and deviations” shows just some of the faults the US regulator has found at a manufacturing site in Gujarat, India. Sun—and now-subsidiary [...]
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