Drugs

CDER Drug Shortage Management Process

FDA has posted seven things consumers should know about how CDER manages drug shortages. The items are:

the CDER Drug Shortage Staff (DSS) is the focal point for evaluating and managing drug shortages;
for many drugs, manufacturers must notify FDA about permanent discontinuances in manufacturing and manufacturing interruptions that are likely to lead to a meaningful disruption in the drug’s supply, and they also must develop and maintain a risk management plan evaluating risks to the supply of their product;
the DSS will consider that a product is in shortage if three specific criteria are present;
CDER posts drugs on the Drug Shortage Database once they are determined to be in shortage;
DSS is responsible for coordinating all activities related to the prevention and mitigation of drug shortages;
patients, healthcare professionals, and organizations can report new shortages through a public notification portal; and
DSS will consider that a product is resolved if specific criteria are met.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome