Letters, Testimony & Comments

Comment letter to Treasury on the CFIUS pilot program 

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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff. BIO appreciates…

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. 

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

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for rare…

BIO submitted comments to the Food and Drug Administration (FDA) following the public meeting, Patient-Focused Drug Development (PFDD) Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose…

BIO submitted comments on the Food and Drug Administration’s (FDA) open docket, Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments…

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. 

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guideline, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. BIO appreciates FDA’s commitment to harmonization of regulatory concepts…