Letters, Testimony & Comments

Wed, 2007-05-23 01:00
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft guideline The Requirements for First-in-Human Clinical Trials for Potential High Risk Medicinal Products. BIO...
Wed, 2007-05-16 01:00
Dear Chairman Baucus and Ranking Member Grassley:   We applaud your commitment to continue reviewing trade preference programs to identify areas for improvement. As you review these programs, we encourage Congress to consider improvements...
Thu, 2007-05-10 01:00
BIO's presentation to MCAC
Mon, 2007-05-07 01:00
Dear Ms. English: We commend the National Vaccine Advisory Committee (NVAC) for addresssing the challenges of adolescent immunization. The dynamic of immunizations is changing from a model focusing on infants to one recognizing the increasing...
Thu, 2007-04-26 01:00
The Statement of the The Biotechnology Industry Organization On H.R. 1908, The Patent Reform Act of 2007 The United States House of Representatives Committee on the Judiciary Subcommittee on Courts, the Internet, and Intellectual Property...
Wed, 2007-04-25 01:00
The paper details the legal and regulatory implications of the many important differences between biologics and traditional "small molecule" drugs.
Tue, 2007-04-17 01:00
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today on the success of the Prescription Drug User Fee Act (PDUFA) and the proposed enhancements for PDUFA IV. My...
Mon, 2007-04-16 01:00
Regarding their letter to Pharmaceutical Manufacturers on the definition of AMP used to calculate 340B ceiling prices.
Tue, 2007-04-10 01:00
April 10th, 2007 The Honorable Harry Reid Majority Leader United States Senate Washington, DC 20510 Dear MR. Leader: As President & CEO of the Biotechnology Industry Organization (BIO), I am writing to express BIO’s support for...
Tue, 2007-04-03 01:00
BIO's Comments.
Mon, 2007-04-02 01:00
Comments regarding purchasing by state and local governments through Federal Supply Schedules.
Thu, 2007-03-29 01:00
Any Statutory Pathway for the Approval of Follow-On Biologics Must Protect Patient Safety and Preserve Incentives to Innovate
Mon, 2007-03-26 01:00
BIO Submits letter to Congress restating opposition to H.R. 1038.
Thu, 2007-03-15 01:00
BIO letter to the Commonwealth Health Insurance Connector Authority regarding the inclusion of prescription drugs for Minimum Creditable Coverage (MCC) under the Commonwealth Choice program.