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DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

November 19, 2018

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New Report Shows Global Link Between Pro-Innovation Policies and Biotech Advances

Washington, D.C. (November 19, 2018) – A study released today highlights strategies, policies and best practices that have been successful in...

Gene Therapy: Long Term Follow-Up After Administration of Human Gene Therapy Products

November 14, 2018

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Gene Therapy CMC: BIO Comments on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

November 14, 2018

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Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Retinal Disorder and Hemophilia

November 14, 2018 

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Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Rare Diseases

November 14, 2018

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Gene Therapy: BIO Comments on Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

November 14, 2018

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BIO Releases Third Report in a Series on the State of Innovation in Highly Prevalent Chronic Diseases

Washington, DC (October 26, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Volume III Type 2 Diabetes and Obesity Therapeutics, the third in a series on the current funding and R&D landscape for drugs to treat highly prevalent, chronic diseases.

BIO Applauds International Support of Agricultural Applications of Precision Biotechnology

The following statement may be attributed to Joseph Damond, Executive Vice President, International Affairs for the Biotechnology Innovation Organization, in response to the United States and 12 other nations signing on to the International Statement on Agricultural Applications of Precision Biotechnology. The joint statement supports policies that enable agricultural innovation, including genome editing.

BIO Welcomes Announcement of FDA’s Plant and Animal Biotechnology Innovation Action Plan

Washington, D.C. (November 1, 2018) – The Biotechnology Innovation Organization (BIO) released the following statement regarding the U.S. Food and Drug Administration (FDA) Plant and Animal Biotechnology Innovation Action Plan: