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Fee Diversion: BIO Joins Broad Coalition to Support End of Fee Diversion at PTO

Jun 13 2011
Absent a statutory mechanism to prevent future fee diversion, the existing and new responsibilities vested in the U.S. Patent and Trademark Office (PTO) will suffer, the ability of the PTO to plan long-term and build the agency our innovation economy demands will be frustrated, and the job-stifling patent application backlog will continue.

BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Jun 9 2011
BIO generally supports and agrees with FDA's statements that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the 351(k) pathway also presents unique challenges compared to existing programs.

BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA); Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017"

Jun 9 2011

BIO's Comments on the CMS Accountable Care Organizations Proposed Rule

Jun 6 2011
BIO appreciates the steps CMS has taken to minimize adverse incentives under risk-based arrangements, but believes that more must be done to ensure that beneficiaries that are treated by ACO participants have timely access to novel, innovative therapies. In the comments, BIO addresses matters such as the ACO quality measures, beneficiary protections, access to innovative new technologies and maintaining the integrity of the shared savings program.

BIO Submits "Guideline on similar biological medicinal products containing monoclonal antibodies" Comments to the European Medicines Agency (EMA)

May 31 2011
In the comments, BIO acknowledges that the guideline is useful and contributes guidance to those planning to develop biosimilar versions of existing originator monocolonal antibodies. However, since the Guideline attempts to cover a very wide and diverse group of products it has to allow for a range of circumstance and be potentially very flexible.

BIO Submits Comments to FDA on "Draft Guidance for Industry on Medication Guides—Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies"

May 31 2011

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BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)

May 31 2011

BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)

May 31 2011

BIO provides specific comments and requests clarifications on the text of the Guideline regarding the variability of immunogenicity, approaches for predicting and reducing immunogenicity,...

Driving Innovation and Job Growth Through the Life Sciences Industry

May 25 2011

Driving Innovation and Job Growth Through the Life Sciences Industry

May 25 2011
Representatives of the bioscience industry testified before the U.S. Congress Joint Economic Committee today, as part of a hearing entitled Driving Innovation and Job Growth through the Life Sciences Industry.