S.623 - Federal Government - A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/15/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the [...]

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