Press Releases

April 23, 2012

Washington Update: Mark McClellan & Ellen Sigal Op-Ed Supporting FDA Breakthrough Designation

BREAKTHROUGH THERAPIES PROGRESS UPDATE: Former FDA Commissioner Dr. Mark McClellan and Friends Chair Dr. Ellen Sigal Pen Op-Ed Supporting Breakthrough Designation   Over 45 Organizations Sign Congressional Support Letter for Breakthrough Therapies Designation to be Included in PDUFA V    March 26, 2012: The “Advancing Breakthrough Therapies for Patients Act of 2012” was introduced by Senators Bennet (D-CO) Hatch (R-UT) and Burr (R-NC). For…

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April 19, 2012

House Energy and Commerce Committee Subcommittee on Health Hearing – “FDA User Fees 2012: How Innovation Helps Patients and Jobs”

On Wednesday, April 18, 2012, the House Energy and Commerce Committee, Subcommittee on Health, held the seventh hearing on the FDA since February and the latest in a series of hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA).  The two-panel hearing discussed some of the specific points of the most recent…

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March 29, 2012

Washington Update: New FDA Legislation Introduced, Friends holds Senate Briefing on Approval Mechanisms

   Senators Bennet, Hatch and Burr Introduce Bipartisan Bill to Bring Breakthrough Treatments  to Patients More Quickly    On March 26, 2012, U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT) and Richard Burr (R-NC) introduced The Advancing Breakthrough Therapies for Patients Act to help bring breakthrough drugs and treatments to patients who need them more quickly.…

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March 29, 2012

Senate HELP Full Committee Hearing – FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients

The Senate Committee on Health, Education, Labor, and Pensions convened a hearing Thursday, March 29, 2012, to discuss the various user fee agreements up for reauthorization or approval.  The hearing featured two panels: the first panel with government officials and the second with members of industry and trade organizations.  The hearing called attention to the…

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March 26, 2012

Bennett, Hatch and Burr Introduce Bipartisan Bill to Bring Breakthrough Treatments to Patients More Quickly

Bill Would Expedite FDA Approval and Increase Clinical Trial Flexibility of Drugs and Treatments That Show Dramatic Early Responses – Washington, DC – Senators Michael Bennet (D-CO), Orrin Hatch (R-UT) and Richard Burr (R-NC) today introduced a bipartisan bill to help bring breakthrough drugs and treatments to patients who need them more quickly. The Advancing…

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March 23, 2012

SOCIETY OF SURGICAL ONCOLOGY NAMES LISA C. PAULSEN RECIPIENT OF THE 2012 JAMES EWING LAYMAN'S AWARD

The SSO Recognized Paulsen for Her Leadership of the Entertainment Industry Foundation, Including Her Efforts in the Creation of the “Stand Up To Cancer” Initiative – Los Angeles, CA  – March 23, 2012  – The Society of Surgical Oncology (SSO) and its James Ewing Foundation recognized the efforts of Stand Up to Cancer’s co-founder Lisa…

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March 8, 2012

House Energy and Commerce Committee, Subcommittee on Health Hearing – “FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain”

Thursday, March 8, 2012, the House Energy and Commerce Committee Subcommittee on Health held a hearing titled, “FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.”  The three panel hearing convened members of government, academia, and industry to address pressing issues surrounding the reauthorization…

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February 9, 2012

House Energy and Commerce Committee Subcommittee on Health: Review of the Proposed Generic Drug and Biosimilar User Fees and Further Examination of Drug Shortages

On Thursday, February 9, 2012, the House Energy and Commerce Subcommittee on Health held the second in a series of hearings regarding the reauthorization of the Prescription Drug User Fee Act, the Medical Device User Fee Act, and the creation of the Generic User Fee and Biosimilar User Fee Acts.  The two-panel hearing also covered…

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February 2, 2012

House Energy and Commerce Committee, Subcommittee on Health Hearing – Reauthorization of PDUFA: What It Means for Jobs, Innovation, and Patients

On Wednesday, February 1, 2012, the House Energy and Commerce Subcommittee on Health held a hearing to discuss the upcoming reauthorization of the Prescription Drug User Fee Act, among other things.  FDA Commissioner Dr. Margaret Hamburg served as the witness to the first panel.  A second panel consisted of Geno Germano, president and general manager…

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January 13, 2012

FDA Press Release on Commitment Letter for PDUFA

The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.…

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