Enhanced Security for Medical Supply Chain: Drugs and Devices
This act aims to enhance the security of the medical supply chain for drugs and devices in the United States. It introduces new requirements for manufacturers to regularly report their production capacities, locations, and sourcing of components to the FDA. This ensures better availability of essential medical products for citizens and quicker responses to potential shortages.
Key points
Manufacturers of essential drugs and medical devices must annually provide the FDA with detailed information on their production capacity, including manufacturing locations and component sourcing.
The FDA will be able to expedite the review of devices that can help mitigate or prevent drug or device shortages.
The definition of 'shortage' is expanded to include both drugs and medical devices, allowing for more comprehensive monitoring and crisis management.
Expired
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