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Food and Drug Administration

Developing Policies that Foster Innovation
March 28, 2012

Acorda Therapeutics' Ron Cohen presented testimony on the importance of federal policies...

Panelists Go Inside the FDA at the BIO CEO & Investor Conference
February 22, 2012

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City...

FY2011 Innovative Treatment Approvals
November 3, 2011

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for...

PDUFA V Recommendations Promote Development of Innovative Therapies
November 3, 2011

Underlying the PDUFA V recommendations are the principles that a science-based, transparent,...

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Letters, Testimony & Comments

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...
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...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
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Press Releases

Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
Washington, D.C. (February 1, 2012) – Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf...
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
Washington, D.C. (October 4, 2011) – A coalition of anti-technology groups under the moniker “Just Label...
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Washington, D.C. (September 1, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Washington, D.C. (August 3, 2011) – In a letter to Congressional Leadership, the Biotechnology Industry...
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