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August 2015 Archives

OSHA expands whistleblower 'early resolution' process

Only nine days old, the U.S. Occupational Safety and Health Administration has put in place a new "early resolution" process intended to resolve whistleblower disputes under the agency's regional Alternative Dispute Resolution, or ADR, program.

OSHA expands whistleblower 'early resolution' process

Only nine days old, the U.S. Occupational Safety and Health Administration has put in place a new "early resolution" process intended to resolve whistleblower disputes under the agency's regional Alternative Dispute Resolution, or ADR, program.

Believe it: more suspected duodenoscope 'superbugs'

Bacteria-resistant infections potentially connected to procedures involving the reusable duodenoscope have been reported across the country, notably in Southern California, where reportedly three infected patients died. If manufacturers and federal officials had thought they had contained the problem, they were mistaken, as another hospital announced Wednesday that some of its patients developed a suspected duodenoscope-related infection.

Believe it: more suspected duodenoscope 'superbugs'

Bacteria-resistant infections potentially connected to procedures involving the reusable duodenoscope have been reported across the country, notably in Southern California, where reportedly three infected patients died. If manufacturers and federal officials had thought they had contained the problem, they were mistaken, as another hospital announced Wednesday that some of its patients developed a suspected duodenoscope-related infection.

Who'd be liable for injury due to medical device hack?

Right now, the issue is seen as largely theoretical but experts in the area of cybersecurity say it is a focus of serious concern. What would happen if hackers took over the computers controlling medical implants, turning them from life-saving devices into tools of potential injury or death?

Who'd be liable for injury due to medical device hack?

Right now, the issue is seen as largely theoretical but experts in the area of cybersecurity say it is a focus of serious concern. What would happen if hackers took over the computers controlling medical implants, turning them from life-saving devices into tools of potential injury or death?

Federal court's drug marketing ruling a Risperdal reminder

An Aug. 7 ruling by a federal district court in New York raised the issue of whether a drug company is culpable of "misbranding" a drug, in violation of federal regulations, when the company markets the drug for a purpose unapproved by the U.S. Food and Drug Administration. The case did not address in any way U.S. Justice Department and FDA proceedings in regard to the antipsychotic Risperdal, but it did address the broader issue of how far a drug company can go in the so-called "off-label" marketing of its product.

Federal court's drug marketing ruling a Risperdal reminder

An Aug. 7 ruling by a federal district court in New York raised the issue of whether a drug company is culpable of "misbranding" a drug, in violation of federal regulations, when the company markets the drug for a purpose unapproved by the U.S. Food and Drug Administration. The case did not address in any way U.S. Justice Department and FDA proceedings in regard to the antipsychotic Risperdal, but it did address the broader issue of how far a drug company can go in the so-called "off-label" marketing of its product.

Clock Ticking on Hurricane Sandy Insurance Reviews

About 142,000 Hurricane Sandy victims have until Sept. 15 to file for a review by the Federal Emergency Management Agency of what they feel is low-balled compensation of their flood insurance claims related to the 2012 Atlantic storm. Meanwhile, with the clock ticking and many New Jersey policyholders uncertain as to how to proceed, members of the New Jersey congressional delegation sent a letter to FEMA Thursday requesting that the deadline be pushed back to Dec. 15.

Clock Ticking on Hurricane Sandy Insurance Reviews

About 142,000 Hurricane Sandy victims have until Sept. 15 to file for a review by the Federal Emergency Management Agency of what they feel is low-balled compensation of their flood insurance claims related to the 2012 Atlantic storm. Meanwhile, with the clock ticking and many New Jersey policyholders uncertain as to how to proceed, members of the New Jersey congressional delegation sent a letter to FEMA Thursday requesting that the deadline be pushed back to Dec. 15.

FDA tracking MS drug's link to brain infection

There is no telling yet whether a certain multiple sclerosis drug actually causes a brain infection; nevertheless, the U.S. Food and Drug Administration announced Aug. 4 the emergence of a couple of cases that apparently raised suspicions. We will simply have to wait and see the outcome of further FDA investigations.

FDA tracking MS drug's link to brain infection

Gilenya_Brain_Infection.jpgThere is no telling yet whether a certain multiple sclerosis drug actually causes a brain infection; nevertheless, the U.S. Food and Drug Administration announced Aug. 4 the emergence of a couple of cases that apparently raised suspicions. We will simply have to wait and see the outcome of further FDA investigations.

Mouse study suggests hearing loss risks from antibiotic drug

Antibiotic drugs are important weapons in the health care arsenal. Unfortunately, they also represent something of two-edged sword. They can knock out potentially deadly bacterial infections in the body. But experts generally agree that overuse has allowed bacteria to develop resistance. Some antibiotics aren't as effective as they once might have been.

Mouse study suggests hearing loss risks from antibiotic drug

Antibiotic drugs are important weapons in the health care arsenal. Unfortunately, they also represent something of two-edged sword. They can knock out potentially deadly bacterial infections in the body. But experts generally agree that overuse has allowed bacteria to develop resistance. Some antibiotics aren't as effective as they once might have been.

FDA issues new 'scope' superbug prevention procedures

The use of the duodenoscope, which is used to examine a part of the small intestine, has been linked to the outbreak of drug-resistant so-called "superbugs" at hospitals in Los Angeles and elsewhere in the U.S. While some of the victims have filed product liability lawsuits against one of the device's leading manufacturers, the U.S. Food and Drug Administration has issued a new list of measures intended to clean the device between uses.

FDA issues new 'scope' superbug prevention procedures

duodenoscope_lawsuit_cleaning.jpgThe use of the duodenoscope, which is used to examine a part of the small intestine, has been linked to the outbreak of drug-resistant so-called "superbugs" at hospitals in Los Angeles and elsewhere in the U.S. While some of the victims have filed product liability lawsuits against one of the device's leading manufacturers, the U.S. Food and Drug Administration has issued a new list of measures intended to clean the device between uses.

Studies published on SSRI antidepressants and birth defects

A pair of respected medical journals published studies within the last couple of months that linked the expectant mother's use of selective serotonin reuptake inhibitor antidepressants with certain birth defects. The findings were released while SSRI antidepressant lawsuits have been filed against the makers of some of these popular drugs. Plaintiffs alleged the birth defects connection.

Studies published on SSRI antidepressants and birth defects

A pair of respected medical journals published studies within the last couple of months that linked the expectant mother's use of selective serotonin reuptake inhibitor antidepressants with certain birth defects. The findings were released while SSRI antidepressant lawsuits have been filed against the makers of some of these popular drugs. Plaintiffs alleged the birth defects connection.

Study suggests simple way to improve chemo drug performance

Chemotherapy is a powerful tool in the fight against many different forms of cancer. The problem with it is that the chemicals that are used can be deadly. Doctors don't want to give patients too much of the stuff. If they do, the intended cure could be worse than the disease.

Study suggests simple way to improve chemo drug performance

Chemotherapy is a powerful tool in the fight against many different forms of cancer. The problem with it is that the chemicals that are used can be deadly. Doctors don't want to give patients too much of the stuff. If they do, the intended cure could be worse than the disease.

OSHA clarifies worker injury data collection requirement

The federal agency charged with setting and enforcing workplace safety standards published a proposed rule Wednesday in the Federal Register intended to ensure employers would be aware of their duty to track and to report workplace illnesses and injuries. The U.S. Occupational Safety and Health Administration published the rule to clarify that such recordkeeping is an "ongoing obligation."

OSHA clarifies worker injury data collection requirement

The federal agency charged with setting and enforcing workplace safety standards published a proposed rule Wednesday in the Federal Register intended to ensure employers would be aware of their duty to track and to report workplace illnesses and injuries. The U.S. Occupational Safety and Health Administration published the rule to clarify that such recordkeeping is an "ongoing obligation."

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