News Roundup: The FDA's Drug Approval Process, Improper Breathalyzer Calibration, and More

Our news roundup this week focuses on the FDA’s drug approval process, a potential Alzheimer’s treatment, and the effects of improper calibration of breathalyzers in Massachusetts. Every week we add interesting news and information relating to metrology, pipetting, ISO standards, and more. You can find these stories, as well as others, on our Industry News page.

Here are this week's highlights:

FDA’s Role in the Drug Approval Process: The FDA plays an important role in protecting consumers from drugs that may be harmful, or simply not effective. Without proper regulation, pharmaceutical companies would not be held accountable for fraudulent claims regarding new drugs being brought to market. This article covers the process a drug must go through before being accepted by the FDA, including:

  • drug development,
  • animal testing,
  • submittal of an Investigational New Drug application,
  • clinical trials,
  • submittal of a New Drug Application,
  • drug labeling, facility inspection, and, finally,
  • drug approval.

  • Prescription and over-the-counter drugs must both be approved by the FDA in similar fashions. For more details regarding this process, click the link to the full article from HealthyChildren.org.

    Study: Cancer drug found to restore memory in mice holds promise as Alzheimer’s treatment: Saracatinib, a drug used to treat cancer, has been found to help restore memory in mice with cognitive disorders. Researchers at Yale University have been working in collaboration with the National Institutes of Health (NIH), an organization expected to receive a ten percent increase in funding for this research in the coming year.

    The Washington Post reports that the drug works by targeting beta amyloid deposits in the brain and lowering their toxic effect on nearby cells. Beta amyloid is often a precursor to Alzheimer's disease. Use of the drug on mice has proven to reverse cognitive problems, including those similar to Alzheimer's. Though optimistic, researchers caution that the effect on humans is still unclear, and further research must be conducted to conclude whether or not the findings can lead to a cure for Alzheimer's.

    MA says Breathalyzers are working properly; Northwestern district attorney’s office to continue review of local cases: Breathalyzers are facing some scrutiny recently as a report claims that around 150 cases have been ruled invalid due to improper calibration. The Massachusetts state Executive Office of Public Safety and Security says that the breathalyzers themselves are functioning properly, but the machines are not being properly calibrated by officers prior to performing the test. This article from Gazettenet has the full story.

    Calibration is essential to accurate results, as can be seen in this scenario. Is your lab equipment being properly calibrated? How accurate are your pipette results? TTE Laboratories is committed to providing pipette calibration services that are comprehensive and complete, reliable and fully compliant to ISO 8655 requirements. Visit our ISO Calibration Services page to learn more.

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