legislation: 111-hr-6331

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
111-hr-6331 111 hr 6331 Generating Antibiotic Incentives Now Act of 2010 Health 2010-09-29 2010-09-29 Referred to the House Committee on Energy and Commerce. House Rep. Gingrey, Phil [R-GA-11] GA R G000550 4 Generating Antibiotic Incentives Now Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) extend for five years the exclusivity period for the first licensure of a qualified infectious disease product; (2) grant priority review to an application for approval or licensure of a qualified infectious disease product (i.e., review and action on such application not later than six months after receipt); and (3) deem a qualified infectious disease product as a fast track product, for review and approval purposes.  Defines "qualified infectious disease product" as an antibiotic drug, or a diagnostic test including a point-of-care diagnostic test, for treating, detecting, preventing, or identifying a qualifying pathogen.  Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to review the guidelines of the Food and Drug Administration (FDA) for the conduct of clinical trials for antibiotic drugs and revise such guidelines to reflect developments in medical information and technology.  Allows the sponsor of a drug intended to be used to treat, detect, prevent, or identify a qualifying pathogen, as defined by this Act, to request that the Secretary provide written recommendations for nonclinical and clinical investigations before such drug may be approved for use or licensed. 2023-01-11T13:21:30Z  

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