Biomarkers: BIO Submits Comments on FDA Draft Guidance Biomarker Qualification: Evidentiary Framework

Feb 14 2019

February 11, 2019


RWE: BIO Submits Comments on FDA Framework for a Real-World Evidence Program

Feb 8 2019

February 5, 2019


BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies

Jan 17 2019

BIO urges the Administration to fully assess the potential impact of export controls on biotechnologies on “the impact on the economy of the United States” and on the sustainability of the U.S....

BIO's Comments on the Expanded CFIUS Review Pilot Program

Jan 15 2019
Comment letter to Treasury on the CFIUS pilot program 

BIO Comments on FDA Draft Guidance Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

Jan 2 2019

December 17, 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

Jan 2 2019

December 14, 2019


BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

Jan 2 2019

December 18, 2019


Advance Notice of Proposed Rulemaking: International Pricing Index Model for Medicare Part B Drugs

Dec 31 2018
BIO strongly opposes the potential proposal detailed in the Advance Notice of Proposed Rulemaking (ANPRM) on the International Pricing Index (IPI) and calls for withdrawal of the IPI model in its entirety.

BIO Letter to POTUS on U.S./China Trade

Dec 20 2018
The following letter was sent to the President of the United States in response to talks between the U.S. and China related to trade. 

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.