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BIO Comments on the CARB on the Harmonization Chapter

Oct 21 2011
BIO comments on the draft “Harmonization” chapter (the chapter) of CARB report.

Paraguay IP Section 306 Monitoring: BIO Comments

Oct 20 2011
BIO urges the United States Trade Representative to continue to address the persistent deficiencies in patent protection and data protection regimes in Paraguay.  These deficiencies raise issues in respect to Paraguay's bilateral and international obligations and deny adequate and effective protection for the intellectual property rights of BIO's members.

NADAC: BIO's Comments on the Survey of Retail Prices

Oct 20 2011

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Mobile Medical Applications: BIO Comments

Oct 19 2011

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Therasense USPTO Implementation: BIO Comments on the Revision of the Standard for the Duty to Disclose

Oct 19 2011
BIO believes the Therasense decision marks an important positive step in the evolution of the inequitable conduct doctrine, and appreciates and applauds its quick embrace by the USPTO.  BIO believes that the decision, in conjunction with the Leahy-Smith America Invents Act of 2011, offers opportunities to re-think and restructure administrative applicant disclosure obligations in ways that go beyond what would be possible under the USPTO’s proposed revised Rule alone.  

Companion Diagnostics: BIO Comments on FDA Draft Guidance

Oct 14 2011

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Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard

Oct 4 2011
Brief, high level comments in response to the model structure and parameter changes; specifically related to GTAP work on indirect land use change (ILUC), and other indirect effects from biofuel production.

Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard

Oct 4 2011
Brief, high level comments in response to the model structure and parameter changes; specifically related to GTAP work on indirect land use change (ILUC), and other indirect effects from biofuel production.

Affordable Care Act: BIO Comments on Coverage of Preventive Services by Group Health Plans and Health Insurance Issuers

Sep 30 2011

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CDER Science & Research Needs: BIO Comments on CDER Draft Report

Sep 26 2011
Ongoing efforts to prioritize regulatory science research objectives coupled with clear and achievable milestones will help to encourage productive partnerships between FDA, the private sector, and academia to successfully modernize drug development and evaluation methodologies, and ultimately provide patients with access to safe and effective new therapies.