legislation: 109-s-4016

Congressional bills and resolutions from Congress.gov, filtered to policy areas relevant to environmental, health, agriculture, and wildlife regulation.

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bill_id congress bill_type bill_number title policy_area introduced_date latest_action_date latest_action_text origin_chamber sponsor_name sponsor_state sponsor_party sponsor_bioguide_id cosponsor_count summary_text update_date url
109-s-4016 109 s 4016 Access to Life-Saving Medicine Act Health 2006-09-29 2006-09-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Senate Sen. Schumer, Charles E. [D-NY] NY D S000148 3 Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of a comparable biological product based on its similarity to a previously licensed biological product (the reference product). Allows a person to file an abbreviated comparable product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the comparable product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the comparable product are the same as those of the reference product. Sets forth conditions for approval of such an application by the Secretary. Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product. Provides market exclusivity to such an interchangeable product. Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications. Sets forth provisions governing patent infringement claims against the license holder of a comparable product. 2023-01-12T17:52:02Z  

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