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Health Care

Orphan Drugs: Making Rare Disease Rarer
February 12, 2013

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New...

The 340B Drug Discount Program
February 12, 2013

Congress created the 340B program in 1992 to help uninsured indigent patients gain better...

Biotech in China
February 1, 2013

The biosimilars pathway is critical for China's biotechnology industry – and this is...

Renewing the Project BioShield Act
January 29, 2013

In the next several months, the president and members of Congress will decide whether to...

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Letters, Testimony & Comments

BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter
March 1 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
Medicaid, Children’s Health Insurance Programs, and Exchanges
February 21 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
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Press Releases

BIO Praises U.S. Senate for Passing the Pandemic and All-Hazards Preparedness Reauthorization Act
February 28 2013
WASHINGTON, DC – February 28, 2013 –The Biotechnology Industry Organization (BIO) lauds the Senate for...
BIO Praises The House of Representatives for Approving H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act
January 25 2013
The Biotechnology Industry Organization lauds the House of Representatives for passing H.R. 307, the Pandemic and All...
PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
IFPMA, BIO and WADA Advance Anti-Doping Collaboration with the Launch of 2 Fields 1 Goal Campaign
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
Supreme Court Affordable Care Act Ruling Must Now Lead to Implementation That Will Promote Innovation and Expand Access
June 28 2012
  Pleased to move forward on biosimilars pathway Washington, D.C. (June 28, 2012) –Biotechnology...
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