Industry Best Practices

November 30, 2011

Jobs and salaries in this industry have substantially grown in the past ten years. To date,...

March 29, 2011

Patent systems can provide an advantage to society by rewarding the development of new...

May 25, 2010
October 8, 2009

BIO released a survey on licensing trends between universities and companies.

Letters, Testimony & Comments

April 2 2014
BIO joins coalition letter to Chairman Patrick Leahy and Ranking Member Chuck Grassley expressing serious concerns with the direction of patent legislation.
March 1 2012
  Comments on a proposed Texas Administrative Code that would classify biologics as specialty drugs. 
April 18 2011
BIO supports the Agency's efforts to fully utilize new electronic health care data sources for post-approval pharmacoepidemiologic studies. These new data resources offer great promise to revolutionize the practice of pharmacovigilance with more timely and cost-effective methods for conducting post-market studies, but great care must be taken to minimize the potential for confounding and bias. We hope the Draft Guidance will provide additional transparency in scientific exchange between FDA and Sponsors when initiating appropriate pharmacoepidemiological studies in a regulatory context. With this goal in mind, we request clarification of several aspects of the Draft Guidance, particularly around the process for submitting and reviewing study protocols.
April 13 2009
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Good Importer Practices. This guidance provides a useful quality systems framework for importers across all FDA-regulated industries to promote the safety of imported products. Biotechnology companies are currently leading significant efforts to further enhance the safety and security of biopharmaceuticals at every step of the supply chain and we encourage the FDA to minimize the potential for divergence between this guidance and current drug and biologic Good Manufacturing Practices regulations.

Press Releases

April 16 2015
BIO commends Senate Finance Committee Chairman Orrin Hatch (R-UT), Ranking Member Ron Wyden (D-OR) & House Ways & Means Chairman Paul Ryan (R-WI) for introducing the Bipartisan Congressional Trade Priorities Act of 2015
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.