H.R.1038 - To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

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

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01/04/09
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). ...

Source: Patent Docs
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12/30/08
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 ...

Source: Eye on FDA
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12/28/08
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 ...

Source: Eye on FDA
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12/20/08
Eye on FDA: Weekly Roundup - 12/19/08

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 ...

Source: Eye on FDA
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12/17/08
Eye on FDA: FDA Announces New Recommendations on Evaluating ...

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 ...

Source: Eye on FDA
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12/11/08
Eye on FDA: Weekly Roundup - 12/12/08

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 ...

Source: Eye on FDA
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12/09/08
Eye on FDA: Full Disclosure on Complete Response Letter by Targanta

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 ...

Source: Eye on FDA
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12/08/08
Eye on FDA: DTC in the Crosshairs of Congressman Waxman

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 ...

Source: Eye on FDA
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12/04/08
Eye on FDA: Weekly Roundup - 12/05/08

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 ...

Source: Eye on FDA
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12/03/08
Eye on FDA: The Tom Daschle Appointment for HHS - What's Inside?

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 ...

Source: Eye on FDA
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12/02/08
Eye on FDA: The Changing Policy and Communications Environment and ...

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 ...

Source: Eye on FDA
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11/26/08
Eye on FDA: Happy Thanksgiving Everyone

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 ...

Source: Eye on FDA
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11/25/08
Eye on FDA: Advice for the Obama FDA Commissioner, Part 2

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 ...

Source: Eye on FDA
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11/23/08
Eye on FDA: Advice for Obama's FDA Commissioner - Part 1

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 ...

Source: Eye on FDA
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11/22/08
Eye on FDA: American Health and Drug Benefits

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 ...

Source: Eye on FDA
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11/21/08
Eye on FDA: World AIDS Day

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 ...

Source: Eye on FDA
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11/16/08
Eye on FDA: Correction From Friday's Posting

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 ...

Source: Eye on FDA
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09/24/08
CQ Politics | Report: Increased Competition Will Produce Better ...

The group favors legislation ( HR 1038 ) sponsored by Rep. Henry A. Waxman , D-Calif., that would provide an abbreviated pathway for the approval of follow-on biologic drugs. Biotechnology industry representatives disagreed with the ...

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09/18/08
CQ Politics | Less Is Better On Biologic Exclusivity, Candidates ...

Makers of generic drugs favor legislation ( HR 1038 ) sponsored by Rep. Henry A. Waxman , D-Calif., that would provide an abbreviated pathway for the approval of follow-on biologic drugs and includes no period of data exclusivity for ...

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07/11/08
fop political bias extremely partisan

hr 1038 (jackson, d-il) would impose a moratorium on the imposition of the death penalty at the federal level until a national commission on the death penalty reviews its fairness; * hr 1907 (norton, d-dc), the "racial profiling ...

Source: DEHIBITION
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06/30/08
What should the US do about the millions of illegal immigrants now ...

What should the US do about the millions of illegal immigrants now living in this country? The Republican incumbent Saxby Chambliss: Congress must make every effort to secure our borders and enforce our existing laws. ...

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06/27/08
MedWorm Query: cialis online (50 сообщений)

would allow for a 14-year period of data exclusivity, while another bill (HR 1038) by Rep. Henry Waxman (D-Calif.) contains no exclusivity period (McCarthy, CQ HealthBeat, 6/26). The report is available online. ...

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06/18/08
house commerce committee posts responses to its questions on ...

henry waxman (d-ca), who is also a member of the subcommittee, introduced the access to life-saving medicine act (hr 1038). energy and commerce committee member jay inslee (d-wa) also introduced a bill in april 2007 – the patient ...

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05/20/08
Patent Litigation Under a Future Biosimilars Act

Henry Waxman introduced the first of the four biosimilars bills, the Access to Life-Saving Medicine Act (HR 1038), on February 14, 2007. The Waxman bill is regarded as the one most favorable to the generic drug industry. ...

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04/10/08
coalition releases letter in support of follow-on biologics

follow-on biologic advocates support legislation (hr 1038) by house committee on oversight and government reform chair henry waxman (d-calif.) that would not provide brand-name biologics an exclusivity period. last year, the coalition ...

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04/06/08
follow-on biologics: intellectual property and innovation issues

legislation has been introduced in the 110th congress that would create an expedited marketing approval pathway in the public health service act. the access to life-saving medicine act, introduced as hr 1038 and s. 623, would grant the ...

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03/05/08
NFIB.com - NFIB/Georgia News From the Gold Dome -- March 3, 2008

HR 1038 allows for a repeal of inventory taxes levied specifically on retail furniture businesses. Because these resolutions propose to amend Georgia's Constitution, to be enacted they will require a two-thirds vote supermajority in the ...

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02/11/08
Lawmakers Push for Biosimilar Legislation in New Healthcare Initiative

Access to Life-Saving Medicine Act, H.R. 1038, which would let the FDA approve biosimilars as interchangeable with the reference biologics, and Rep. Jay Inslee’s (D-Wash.) Patient Protection and Innovative Biologic Medicines Act, ...

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01/29/08
Nelson Mullins | Newsletters

HR 1038- Rep. Stephens (R-Savannah) Ad Valorem tax; inventories of retail furniture businesses; authorize exemption, is assigned to Ad valorem Sub Committee. HR 1056- Rep. Mills (R-Gainesville) Sales and use tax; educational purposes; ...

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01/18/08
Nelson Mullins | Newsletters

HR 1038 – Rep. Stephens (R-Savannah) proposed an amendment to the Constitution to exempt inventories of retail furniture businesses from ad valorem taxation. This proposal is inserted at Article VII, Section II. HR 1056 – Rep. ...

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