Nonclinical Evaluation for Anticancer Pharmaceuticals

Re: Docket No. FDA-2009-D-0006 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals. BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

GENERAL COMMENTS

In some cases throughout the draft guidance, sections are quite declarative and in some cases very general. In the case of the latter, we recommend providing examples of instances where the general proposal for oncology drugs does not apply (i.e. to clarify statements such as “generally not warranted” or “might not be warranted”, “might be exceeded”). This comment applies specifically to Sections B5, Reproduction Toxicology, B8 Immunotoxicology, D3 Evaluation of Drug Metabolites, and D5 Evaluation of Impurities. At places within the draft guidance the terms “anticancer pharmaceuticals”, “biopharmaceuticals,” and “chemotherapeutics” are used. It would be helpful to confirm that the term “anticancer pharmaceuticals” refers to all modalities unless otherwise specified.

 At places within the draft guidance the terms “anticancer pharmaceuticals”, “biopharmaceuticals,” and “chemotherapeutics” are used. It would be helpful to confirm that the term “anticancer pharmaceuticals” refers to all modalities unless otherwise specified.

Please see the attached chart with BIO‟s specific comments. We would be pleased to provide further input or clarification of our comments, as needed.

Sincerely,

/s/

Katie McCarthy

Director, Science and Regulatory Affairs

cc: James Green, PhD (Biogen Idec), Biotechnology Industry representative to ICH S9 Expert Working Group.

*Table extracted