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Biotechnology Innovation Organization and Biominas Brasil to Co-Host BIO Latin America Conference
Business Development, BIO One-on-One Partnering  •  Press Release  •  August 3, 2016
Meeting will bring together biotechnology executives, academics and investors from around the globe 
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New PBS Film and 2016 BIO Animal Biotech Summit Highlight Biotech Solutions to Combating Emerging Infectious Diseases
Press Release  •  August 1, 2016
Programming at this year’s Animal Biotech Summit, Advancing One Health through Biotechnology, will look at how biotechnology can be used in emerging infectious disease surveillance and rapid diagnosis, while highlighting the flexibility biotechnology provides for treating, controlling and preventing these diseases. The 2016 Summit will be held September 21-23, 2016 in Bethesda, Maryland. 
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Pennsylvania Governor Wolf Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines
Press Release  •  July 22, 2016
BIO and Pennsylvania Bio commend Governor Tom Wolf for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.
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Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations
Human Health  •  Letters, Testimony & Comments  •  July 19, 2016
Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.
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SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry
Human Health  •  Letters, Testimony & Comments  •  July 19, 2016
BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.
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Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Letters, Testimony & Comments  •  July 19, 2016
BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but access cannot and should not come at the expense of product quality and patient safety.
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BIO Statement on Prescription Drug User Fee Act Goals Letter
Press Release  •  July 15, 2016
Washington, D.C. (July 15, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding the Prescription Drug User Fee Act (PDUFA) VI goals letter:
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BIO and Nikon Instruments Inc. Jointly announce a new Program for Research Grade Microscope System for BIO Members
Press Release  •  July 15, 2016
BIO and Nikon Instruments Inc. jointly announce a new partnership under the BIO Business Solutions® offerings.
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BIO Applauds Advancement of H.R. 3299
Press Release  •  July 14, 2016
Statement on House Energy & Commerce Committee Passage of H.R. 3299, the Strengthening Public Health Emergency Response Act of 2016
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BIO Applauds Passage of Federal Approach to GMO Disclosure
Press Release  •  July 14, 2016
Washington, D.C. (July 14, 2016) – The Biotechnology Innovation Organization (BIO) welcomes Congressional passage of a federal, uniform approach to GMO disclosure.  
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