Close

Clinical Trials: BIO Comments on FDA Draft Guidance Adaptive Designs for Clinical Trials of Drugs and Biologics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DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers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Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Retinal Disorder and Hemophilia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Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Rare Diseases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

...

BIO Comments on Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

Oct 12 2018

October 12, 2018

...

BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.

Oct 9 2018

October 8, 2018

...