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Medical MalpracticeIs Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]
The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less. Consumer clarity on how certain products make […]
A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency. Researchers compared adverse drug-reaction data for anticonvulsants […]
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses. In the federal case of Amarin Pharma Inc. […]
The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims. Pfizer, the manufacturer of Viagra, did not oppose this request by the Plaintiffs. Pfizer’s attorneys also agreed with the Plaintiffs’ suggestion that all of the pending Viagra […]
Serious Side Effects Associated with Popular Antibiotic Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated with the pills sold commercially as Avelox, Cipro and […]
The American Society for Bone and Mineral Research recently reassessed the efficacy of bisphosphonate, long hailed as a wonder drug for patients with osteoporosis, and its risk factors. Through the course of two clinical trials by the society’s Professional Practice Committee, it was determined that bisphosphonate therapy should be evaluated […]
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are rare, fortunately, but the fact that some are failing to follow it can spell danger […]
More than 1,200 pending lawsuits against Johnson & Johnson involving the company’s iconic baby powder and other products received a big boost when a Missouri jury awarded the family of an ovarian cancer victim $72 million in damages. The case of Jackie Fox, of Birmingham, Ala., who died in October […]
A new report criticizing pharmaceutical companies for releasing incomplete data about the side effects of certain medications should raise a red flag for consumers. The report, issued February 10, 2016, describes information required to be provided to the agency by drug manufacturers as “poor” because it contains holes in key […]
