Letters, Testimony & Comments

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Biomarker Qualification: Evidentiary Framework. The guidance provides industry and FDA staff with recommendations on considerations to address when developing a…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Framework for a Real-World Evidence Program. As required by the 21st Century Cures Act, FDA created this framework for evaluating the potential use of Real-World…

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.’s global leadership in biotechnology, and pursue them …

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to respond to the U.S. Trade Representative’s (USTR) request for comments on negotiating objectives for a United States (US) – United Kingdom (UK) Trade Agreement.

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.

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. 

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.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

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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for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