PDUFA

Andrew Emmett on PDUFA and the 2012 BIO International Convention April 12, 2012 Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...	FY2011 Innovative Treatment Approvals November 3, 2011 BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for...
PDUFA V Recommendations Promote Development of Innovative Therapies November 3, 2011 Underlying the PDUFA V recommendations are the principles that a science-based, transparent,...	Countdown to Partnering - John Carroll, Editor of Fierce Biotech April 7, 2011 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO...

Letters, Testimony & Comments

May 7 2013

Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...

March 1 2013

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...

August 6 2012

Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...

May 30 2012

Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express...

May 10 2012

Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am...

October 1 2012

Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...

June 27 2012

FDASIA headed to President for signature into law Washington, D.C. (June 26, 2012) –Biotechnology Industry...

June 21 2012

Washington, D.C. (June 21, 2012) –Biotechnology Industry Organization (BIO) President and CEO Jim...

May 24 2012

Washington, D.C. (May 24, 2012) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...

May 9 2012

WASHINGTON, DC – (May 9, 2012) – The U.S. regulatory environment strongly impacts innovation and the...