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GUIDANCE DOCUMENT

Nonclinical Safety Evaluation of Drug or Biologic Combinations March 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2005D-0004
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Safety Evaluation of Drug or Biologic Combinations.'' This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2005D-0004.

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