Our Take
Drug shortages are no joke, and the FDA is not backing when when it comes to managing issues surrounding them.
A new rule now requires all drug and biological companies who manufacture medications to notify the FDA six months before discontinuing a drug or a projected shortage.
Shortages can create havoc, and although it has decreased over the last decade, it is still a concern.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage. The rule comes as ...
