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HR 6331 111th Congress House Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Infectious and parasitic diseases Intellectual property Medical research Medical tests and diagnostic methods Prescription drugs

Generating Antibiotic Incentives Now Act of 2010

Introduced: September 29, 2010 See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 29, 2010
Referred to the House Committee on Energy and Commerce.
Sep 29, 2010
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now September 29, 2010

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1