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To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

previous 110th session of congress Other Bill Titles (1 more)

2/14/2007--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... more

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IntroducedresultVoted on by HouseresultVoted on by SenateresultConsidered By PresidentresultBill Becomes Law
February 14, 2007
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March 07, 2007 Senate To Hear About Biogenerics

In summary, HR 1038 would amend section 351 of the Public Health Service (PHS) Act to authorize the Secretary of HHS to approve abbreviated applications for ...

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Source: Patent Baristas, OH


February 16, 2007 Bill Re-Introduced to Create Path for Biogenerics

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced HR 1038, the “Access to Life-Saving Medicine Act,” ...

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Source: Patent Baristas, OH


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January 05, 2009 Patent Docs: Top Stories of 2008: #9 to #6

... exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data exclusivity and eight years of market exclusivity), and S. 623 and H.R. 1038 (which do not address data/market exclusivity). ...

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Source: Patent Docs


December 31, 2008 Eye on FDA: Welcome 2009 - What's in Store for the Pharmaceutical ...

H.R. 1038 - `Access to Life-Saving Medicine Act' · H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study ...

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Source: Eye on FDA


December 29, 2008 Eye on FDA: New Prostate Cancer Treatment Approved by FDA

H.R. 1038 - `Access to Life-Saving Medicine Act' · H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study ...

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Source: Eye on FDA


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