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|a HE 20.4002:D 63/4
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| 245 |
0 |
0 |
|a Guidance for industry and FDA staff :
|b submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product.
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| 246 |
3 |
0 |
|a Submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
|
| 264 |
|
1 |
|a Rockville, MD :
|b U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products,
|c [2004?]
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| 300 |
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|a 7 pages :
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|a text
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|a Mode of access: Internet at the FDA web site. Address as of 7/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147126.pdf ; current access is available via PURL.
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|a Title from PDF title page (viewed on July 16, 2009).
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|a "05/2004"--Online title index.
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|a Dispute resolution (Law)
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|a Chemotherapy, Combination.
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|a United States.
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|a Center for Biologics Evaluation and Research (U.S.)
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