What's going on at the FDA? 10 agency updates

The FDA is a government agency tasked with protecting public health by ensuring prescription drugs are safe and efficient. 

In the last couple of months, the agency has grappled with the coronavirus outbreak, made the rare move to ban a type of medical device and made some prescription drugs available over the counter.

10 FDA updates reported by Becker's Hospital Review since January: 

Editor's note: This is not an exhaustive list. Events are listed in order from most to least recent.

  1. FDA warns of cybersecurity threat in some medical devices
    The FDA has identified a set of cybersecurity vulnerabilities that could allow hackers to access certain medical devices.

  2. FDA makes rare move to ban a type of medical device
    The FDA published a final rule to ban electrical stimulation devices, or ESDs, that are used to prevent self-injurious or aggressive behavior. 

  3. FDA moves to boost supply of face masks for health professionals 
    The FDA granted a request from the CDC to allow healthcare personnel to use face masks regulated by another federal agency during the coronavirus outbreak. 

  4.  FDA tracking 20 drugs for shortages caused by coronavirus
    The FDA is tracking 20 drugs for potential shortages caused by the coronavirus.

  5. FDA launches Purple Book database of biological products 
    The FDA released the first version of the Purple Book, a new online database of biological product information. 

  6. FDA classifies insulin as a biologic in hopes of making it cheaper, more accessible 
    The FDA classified insulin as a biologic product , a move that opens the drug up to more competition, potentially lowering costs for patients who rely on it. 

  7.  FDA makes 3 prescription drugs available over the counter 
    Three drugs that were previously only available with a prescription will be available over the counter. 

  8. FDA, FTC join forces to increase biosimilar availability 
    The Federal Trade Commission and FDA issued a joint statement outlining steps the two agencies plan to boost competition in the biologic drug market. 

  9. FDA asks drugmakers to pull pneumonia drug from the market 
    The FDA requested drugmakers that make bacitracin for injection — a drug to treat infants with pneumonia and empyema — pull it from the market, saying the risks associated with the drug outweigh the benefits. 

  10. New FDA rules aim to cut cost of gene therapy drugs
    The FDA has released six new policies on gene therapy drugs, encouraging drugmakers to bring more of them to the market and lower costs by increasing competition. 

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