Close

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Clinical Trials: BIO Comments on FDA Draft Guidance : Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics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

...

Clinical Trials: BIO Comments on FDA Draft Guidance Adaptive Designs for Clinical Trials of Drugs and Biologics

Nov 28 2018
...

DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers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

...

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

Nov 16 2018

November 14, 2018

...

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

...

Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Retinal Disorder and Hemophilia

Nov 16 2018

November 14, 2018 

...

Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Rare Diseases

Nov 16 2018

November 14, 2018

...

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

Nov 16 2018

November 14, 2018

...

BIO Comments on National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Oct 19 2018

October 18, 2018

...