Letters, Testimony & Comments

On Thursday, January 27th, BIO submitted comments in response to the World Health Organization’s (WHO) recently published white paper on the regulation of Cell and Gene Therapy Products (CGTPs). First and foremost, BIO acknowledged that the…

On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and…

It has been eighteen months since the entry into force of the United States-Mexico-Canada Agreement (“USMCA”), which modernized our trilateral trading relationship in ways that advance the interests of all Americans. The Agreement not only…

The United States-Mexico-Canda Agreement has the potential to deliver tangible benefits for America's workers, farmers, and businesses by improving and strengthening the relationship between the United States and its two closest trading partners…

On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and…

On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices…

BIO is committed to enhancing clinical trial diversity as part of our BIOEquality Agenda published in the fall of 2020. During the pandemic we witnessed biopharmaceutical companies achieve increased clinical trial diversity through commitment and…

On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket…

The Biotechnology Innovation Organization (BIO) welcomes the opportunity to provide comments on the Department for Digital, Culture, Media and Sport’s Public Consultation on reforms to the UK’s data protection regime.

BIO applauds the Subcommittee for examining trade policy and priorities to support agricultural producers, promote innovation, protect the environment and enable agriculture to combat climate change. Because of bipartisan support, for over twenty…