News
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FDA Fails To Protect Against Antibiotic Resistance, Guarantees More Needless Death And Suffering
Antibiotic-resistant bacteria infect two million Americans every year, causing at least 23,000 deaths. Even more die from complications related to the infections, and the numbers are steadily growing. Read More »
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FDA Finally Imposes Some Controls On Agricultural Antibiotics. Sort Of.
This morning, the US Food and Drug Administration dropped some long-awaited-but-still-big news regarding the use of antibiotics in meat production. Tl;dr: The FDA asked (but did not compel) the livestock industry to stop using the micro-dose “growth promoter” antibiotics that are widely believed to contribute to increase in antibiotic resistant bacteria in animals, food and humans. Read More »
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FDA Inaction On Antibiotics Is Making The World Deadlier
This month, the U.S. Food and Drug Administration issued a guidance document (PDF) on the use of antibiotics in farm animals, which accounts for four-fifths of all antibiotics administered in the U.S. [...] The FDA suggests pharmaceutical companies voluntarily change a few labeling and marketing practices to help address that problem. Read More »
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FDA Issues Proposed Rule for Unique Device Identifiers
Five years after a request from Congress, the Food and Drug Administration (FDA) has finally issued a proposed rule that would mandate the placement of unique device identifiers (UDI) on medical devices. Among other things, the use of UDIs will facilitate the reporting of adverse events related to these devices so that the FDA can more quickly address them and recall devices if necessary. Read More »
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FDA Lays Out Rules For Some Smartphone Health Apps
Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. Read More »
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FDA Offers Guide On Wireless Healthcare Devices
The Food and Drug Administration has published a guide to the use of wireless healthcare devices in healthcare settings. Read More »
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FDA Plays Chicken With Antibiotics: Newly Disclosed Documents Reveal Agency's "High Risk" Gamble With Human Health
Here’s some unfortunate, but not so surprising news: The Food and Drug Administration has allowed 30 potentially harmful antibiotic additives to remain approved for use in food animals (cows, pigs and chickens), even though the agency’s own scientists found them to pose a risk to human health or lack necessary data on safety. Read More »
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FDA Proposes Update To mHealth Rule
This week the FDA published a proposed rule updating how the agency would classify those devices. Read More »
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FDA Scrutinizes Antibacterial Products For Hormonal Disruption, Bacterial Resistance
[...] The FDA has announced that it is formally reconsidering “antibacterial” soaps and other personal-care products, charging that the antibacterial ingredients confer no benefit over regular soap and water while carrying extra risks. Read More »
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FDA Seeks Data Mining Tool to Track Adverse Drug Reactions
The Food and Drug Administration is in the market for a data mining tool that will gather information on adverse reactions to vaccines and other drugs, according to solicitation documents posted Monday. Read More »
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FDA Starts Beta-testing 'The Most Advanced Bioinformatics Platform in the World'
The FDA has started testing the precisionFDA platform it developed with DNAnexus. The closed beta test phase is the precursor to a more widespread rollout of the system, which the CEO of DNAnexus has described as being "the most advanced bioinformatics platform in the world." DNAnexus was enlisted by the FDA to help with the project in August...
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FDA Takes Significant Steps To Address Antimicrobial Resistance
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs. Read More »
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FDA Update On Animal Pharmaceutical Industry Response To Guidance #213
On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. [...] FDA asked affected sponsors to notify the agency in writing within three months, or by March 12, 2014, of their intent to engage with FDA as defined in Guidance for Industry (GFI) #213. Read More »
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FDA Wants To Leverage Electronic Medical Records To Probe For Adverse Events
Keeping track of adverse events is a tricky task, even for regulators. Even when a drug has undergone a rigorous premarket assessment process, some risks may not become evident until a product is used by millions. And for other drugs, a particularly rare but serious side effect may take months, if not years, to be identified. Read More »
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FDA Wants To Use EMRs To Streamline Adverse Drug Event Reporting
The U.S. Food and Drug Administration wants to leverage electronic medical records to probe for adverse drug events, according to a recent article in Regulatory Focus. Big data has the power to help expose adverse events more quickly than ever, and the FDA wants to use that to assess drug side effects. Read More »
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