FDA To Help Prevent Drug Shortages
“Under a new proposed rule the FDA would require companies to notify it in advance of any plans to halt production of certain prescription drugs in short supply or of any manufacturing disruptions that could cause temporary shortages of those medications. With a bit more notice, the FDA says, it could better stave off shortages. The FDA’s new requirements would also extend to medically important “biologic” drugs—products composed of sugars, protein or nucleic acids that are typically made from living microorganisms. Shortages of biologics, including a class called sterile injectable drugs, can endanger patients and compromise care.”
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