Close

PFDD: BIO Comments on FDA Draft Guidance Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019

...

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

December 14, 2019

...

BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

December 18, 2019

...

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

December 14, 2018

...

RDOD: FDA Draft Guidance Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

September 25, 2018

...

PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

September 11, 2018

...

BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation

June 8, 2018

...

BIO Statement on Opioid Crisis Response Act of 2018

Washington, DC (April 24, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding S. 2680, the Opioid Crisis Response Act of 2018:

BIO Comments on FDA Draft Guidance Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

March 27, 2018

...

PFDD: BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

Re: Docket No. FDA–2017-N-5896: Public Workshop: Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

...