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Sterility Testing: BIO's Comments on Amendments to Sterility Test Requirements for Biological Products

Sep 19 2011

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Testimony in Support of Economic Development and Jobs for the Michigan Bioscience Industry

Sep 13 2011
These written comments were submitted to accompany the testimony of BIO's Interim Vice President for State Government Relations Pete Pellerito in support of legislative and regulatory environments that benefit biosciences industry job growth.

BIO Comments on CARB Draft Chapter on Environmental Impacts

Sep 12 2011
Comments on the Draft chapter on Environmental Impacts (“the draft chapter”).

BIO Comments on CARB Draft Chapter on Environmental Impacts

Sep 12 2011
Comments on the Draft chapter on Environmental Impacts (“the draft chapter”).

BIO's Comments on PCOR Definition

Sep 2 2011

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BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only

Sep 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).

ICH Q11: BIO Comments on International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances

Sep 1 2011

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Comments to the CY 2012 Outpatient Prospective Payment System (OPPS) Proposed Rule

Aug 30 2011

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2012; Proposed Rule

Aug 30 2011

Nanotechnology: BIO's Comments on Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Aug 15 2011

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