FDA and EMA set out efforts to mitigate GMP-related shortages
Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week.
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Icahn Criticizes Forest Labs on FDA Warning Letter
Activist investor Carl Icahn criticized Forest Laboratories Inc. (FRX) for failing to disclose its latest warning letter from the U.S. Food and Drug Administration for a violation of promotional practices by the company’s sales representatives regarding its drug Daliresp. In a letter to Forest Labs dated Aug. 1 that was recently posted on the agency’s […]
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NIH States That Nemeroff Grant Is Appropriate – Grassley Disagrees
Three months ago, US Senator Chuck Grassley demanded that the National Institutes of Health justify a recent decision to award a multi-million-dollar research grant to Charles Nemeroff, the University of Miami medical school psychiatry chair, who has been at the center of a far-reaching probe into conflicts of interest involving academic researchers and the pharmaceutical […]
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GMP violations and label claims continue to draw FDA warning letters
The US Food and Drug Administration (FDA) has issued two warning letters: One for alleged dietary supplement cGMP violations and the other for disease claims on ‘dietary supplement’ water.
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Recall: Ethicon Endo-Surgery pulls surgical staplers over performance issues
Johnson & Johnson subsidiary Ethicon Endo-Surgery initiated a global recall of certain lots of its Proximate surgical staplers and accessories over concerns about firing issues. Ethicon Endo-Surgery Proximate Surgical Stapler Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery pulled more than 500 lots of its Proximate surgical staplers over performance issues that may cause the devices […]
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Frensenius Threatens to Sue MD Over Clinical Study
source Fresenius Kabi is threatening legal action against a Danish professor after he and several colleagues recently published a paper in The New England Journal of Medicine that concluded its hydroxyethyl starch treatment for sepsis may cause kidney failure and hemorrhages that may lead to patient death, ScienceNordic reports . At the time the study […]
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Court Tells FDA No More Delay on Antibiotic Ban Proceedings
The FDA’s appeal earlier this summer – essentially to escape responsibility from regulating antibiotic overuse in animals – Âfaced a major blow yesterday when a federal court in New York decided the agency cannot avoid its duties any longer. Way to go, judge! The Natural Resources Defense Council (NRDC), along with fellow environmental and public […]
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AmerisourceBergen subpoenaed in U.S. drug probe
Pharmaceutical wholesaler AmerisourceBergen Corp. said Thursday that it has been subpoenaed by the U.S. Attorney’s Office in New Jersey to provide records for a grand jury investigation into illegal use of controlled substances. AmerisourceBergen, which has its headquarters in Chesterbrook and is the third largest drug wholesaler in the country, said that it is cooperating […]
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Forest Labs Receives Untitled FDA Letter On Rep Behavior
source Some physicians have no patience for sales reps who provide incorrect information. So when two Forest Laboratories sales reps last October visited a doctor to discuss the Daliresp medicine for chronic obstructive pulmonary disorder – but minimized the risks, failed to property describe its usage and misleadlingly broadened the indication – the doctor dropped […]
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FDA tells drugmaker quality can’t be added after production
The FDA has told a British maker of homeopathic medicines that some of its products, which anyone can buy off Amazon, qualify as prescription drugs under FDA rules. It also says manufacturing at the company’s Wimbledon plant in London comes up short. In a July 26 warning letter just posted to the FDA site, the […]
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