Drug Discovery and Development

March 25, 2014

The member companies of the Biotechnology Industry Organization (BIO) are committed to...

March 18, 2014

While BIO does not comment on individual companies or their decision-making in regards to...

May 17, 2013

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety...

February 12, 2013

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New...

October 14 2014
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.
May 16 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.
April 14 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. 
September 13 2013
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
March 28 2012
H.R. 4274 will encourage continued investment in pediatric research.
May 25 2011
BIO commends Reps. Davis (D-Ca) and Schwartz (D-PA) for their continued efforts to extend the Qualifying Therapeutic Discovery Project Tax Credit.