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Heading East: Biopharma International Expansion to China and Asia

Dec 17 2018
This Special Report highlights the potential opportunities, entry approaches and local partner selection, and also include recommendations on market acceleration and internationalization.

PFDD: Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments

Dec 14 2018

December 14, 2018

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BIO Comments on USTR Objectives for U.S. – Japan Trade Agreement

Dec 12 2018
BIO supports the U.S. government entering negotiations with the Government of Japan as an opportunity to grow U.S. exports and create U.S. jobs. 

ICH Q12: BIO Comments on ICH Q12 Draft Guideline

Dec 12 2018

December 12, 2018

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BIO's Letters, Comments and Statements on 2018 Farm Bill

Nov 29 2018
The following are letters, comments and statements the Biotechnology Innovation Organization wrote, organized or signed on to with regards to negogiations on the 2018 Farm Bill. 

Clinical Trials: BIO Comments on FDA Draft Guidance : Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

Nov 28 2018

November 28, 2018

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Clinical Trials: BIO Comments on FDA Draft Guidance Adaptive Designs for Clinical Trials of Drugs and Biologics

Nov 28 2018
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DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Nov 19 2018

November 19, 2018

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

Nov 16 2018

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)

Nov 16 2018

November 14, 2018

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