Global Markets & Trade

We engage policymakers and industry partners globally to encourage the adoption of national laws and regulations to support the development of the biotechnology sector.  Pursuing biotechnology specific outcomes within new trade agreements and modernizing older agreements is important as the biotechnology sector is increasingly global, requiring rules to govern the trade in biotechnology product and foster cross-border collaboration.

Letters, Comments & Testimony
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …
November 8, 2021
On Monday, November 8th, BIO submitted comments to the FDA’s draft guidance on Nonclinical Biodistribution Considerations for Gene Therapy Products. In the comment letter, BIO expressed appreciation for the Agency’s decision to put forth a draft guidance that was developed under the auspices of the…
October 29, 2021
The undersigned organizations write to encourage policymakers to remove provisions in the Build Back Better Act that would curtail the effectiveness of Qualified Small Business Stock (QSBS) in incentivizing investment in innovative small businesses and startups. Small businesses and startups are…