Good Health is Your Greatest Wealth……Virgil
The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide. For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down…
The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide. For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down…
The Food and Drug Administration says it has approved the first seasonal flu vaccine made using animal cell technology, rather than the half-century egg method.
WASHINGTON (Reuters) – Democratic and Republican lawmakers said on Thursday they would alter the regulation of drug compounding pharmacies in hopes of preventing more crises like the rare fungal meningitis outbreak that has now cost 32 lives. The outbreak of 461 cases in 19 states has been linked to tainted steroid injections from a Massachusetts pharmacy and led to public condemnation of the U.S. Food and Drug Administration and state pharmacy regulators for failing to act against known problems over the course of a decade. …
(Reuters) – A U.S. Food and Drug Administration panel voted unanimously to recommend the effectiveness of Dynavax Inc’s hepatitis B vaccine Heplisav, but raised concerns about its safety, asking for more data from studies on a wider population. The views of the panel of outside experts were based on data submitted by Dynavax that compared the safety and immunogenicity, or ability to evoke an immune response, of its Heplisav with that of an older vaccine named Engerix B by GlaxoSmithKline Plc. …
The Atlantic Wire reports 5-Hour Energy Drinks are linked with 13 deaths in the past four years. The drinks are also the subject of 90 Food and Drug Administration complaints, including 30 involving life-threatening medical conditions. The medical conditions cited in the filings as possibly caused by the drinks include heart attacks, convulsions, and in one case, a spontaneous abortion, the Atlantic Wire said.
The fungal meningitis outbreak that is affecting 19 states is a tragic commentary on loopholes that exist in the American health care system. Congressional officials and the U.S. Food and Drug Administration are seeking remedies to prevent future situations from developing due to shoddy practices by compounding pharmacies who presently escape the strict oversight traditional pharmaceutical manufacturers face.
The head of the Food and Drug Administration asked Congress Wednesday for more authority to police pharmacies like the one that triggered a deadly meningitis outbreak, even as lawmakers questioned why the agency didn't do more with its existing powers.
WASHINGTON (Reuters) – Two congressional oversight committees will hold hearings next week on the deadly U.S. meningitis outbreak linked to tainted steroid injections and one panel has invited an official from the compounding pharmacy involved, aides said on Monday. The House of Representatives Energy and Commerce Committee expects to hear testimony from Food and Drug Administration commissioner Margaret Hamburg on November 14. …
House lawmakers investigating a nationwide outbreak of deadly meningitis have summoned the head of the Food and Drug Administration to testify at the first congressional hearing on the issue next week.
(Reuters) – The U.S. Food and Drug Administration said on Friday it found “greenish black foreign matter” and other contaminants in an injectable steroid produced by the New England Compounding Center, the pharmacy at the heart of a deadly U.S. meningitis outbreak. It also found that vials from the same bin of the steroid contained what appeared to be a “white filamentous material,” according to the report released by the FDA following inspections of the facility in October. …
(Reuters) – The U.S. Food and Drug Administration said on Monday that it has received reports of five deaths and a heart attack since 2009 that may be associated with Monster Energy Drink. (Reporting by Michele Gershberg; Editing by Gary Hill)