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Comments on FDA's draft Guidance for Reviewers

Dec 5 2003

CMC for Human Somatic Cell Therapy INDs

Letter to James E. Rogan on Unity of Invention

Dec 5 2003

Comments on FDA's draft Guidance for Industry

Dec 4 2003

Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.

BIO/MBC testimony opposing Massachusetts House Bill 3012

Nov 19 2003

The bill proposes a five year ban on open-air plantings of plant-made pharmaceuticals (Nov. 19, 2003).

BIO Comments on FDA's Statement of Work for the Evaluation of First Cycle Review Performance

Nov 17 2003
For the Evaluation of First Cycle Review Performance.

Comments on FDA's Draft Guidance

Nov 5 2003

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Comments on FDA's Draft Guidance For Sterile Drug Products Produced by Aseptic Processing

Nov 5 2003

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Letter from Sens. Olympia J. Snowe, Christopher S. Bond, Robert F. Bennett

Nov 4 2003

Comments on FDA's Counterfeit Drug Task Force Interim Report

Nov 3 2003

BIO Letter to the House Leadership supporting passage of H.R. 1561, the United States Patent and Trademark Fee Modernization Act of 2003

Oct 24 2003
On behalf of the Biotechnology Industry Organization (BIO), I urge you to seek prompt passage of H.R. 1561, the United States Patent and Trademark Fee Modernization Act of 2003.