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Increased Transparency for Biologics Market

New rules aim to increase transparency regarding the availability of biological medicines on the market. Pharmaceutical companies will need to report more quickly whether their products are available for sale, which can help in better supply planning and avoiding shortages. This ensures citizens have up-to-date and easily accessible information about medicines.
Key points
Companies must promptly report the marketing status of biological products.
A one-time report is required for all biological products to confirm availability or withdrawal from sale.
The "Purple Book" information system for biological products is improved for completeness.
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Additional Information
Print number: 117_HR_7035
Sponsor: Rep. Manning, Kathy E. [D-NC-6]
Process start date: 2022-03-09