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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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FDA Goes After Illegal Online Pharmacies Around the Globe

FDA in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection (CBP) also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found [...]

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FDA Inspected Wockhardt US Unit in March

FDA has made some observations about the production process of the US unit of Indian generic drugmaker WockhardtLtd, the company said on Tuesday. The FDA last year banned Wockhardt’s two Indian units from exporting to the United States, its biggest market, citing quality lapses in the manufacturing process. Managing Director Murtaza Khorakiwala told an analysts [...]

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FDA Planning Label Update for Dozens of Drugs

Aiming to jump-start a largely idle safety initiative, the U.S. Food and Drug Administration on Tuesday detailed plans for a government contractor to help pharmaceutical companies update warning labels for hundreds of older products. The move stems from a 2006 regulation known as the physician labeling rule, which required prescription drugs approved after June 30, [...]

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US Marshals Seize $11 Million in Drugs from Ascend Labs

U.S. Marshals seized more than $11 million worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati. Ascend Laboratories is a subsidiary of Alkem Laboratories, one of the top seven pharmaceutical companies in India. Alkem is a vertically integrated organization with 15 manufacturing plants located throughout [...]

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How Safe Are Drugs Made in India?

FDA is cracking down on drug makers selling products in the U.S. (mostly generic drugs) that were made at certain plants in India. On April 1, 2014, the FDA banned U.S. imports of some generic drugs associated with the Canadian drug behemoth Apotex, which like so many drug makers, has a manufacturing presence in India, [...]

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FDA Now Regulating E-Cigs

FDA  plans to begin regulating electronic cigarettes for the first time, banning sales to minors and requiring manufacturers to put health warnings on the nicotine-delivering devices that have become a multibillion-dollar industry, according to officials who described the agency’s proposal. But the agency will stop short of steps that many public health advocates and some [...]

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FDA Now Opposes Aspirin To Prevent Heart Attacks

In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old  petition requesting approval of a primary prevention indication. [PDF of FDA [...]

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