Transcription of Guidance for Industry - Pharmanet
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Guidance for Industry - Pharmanet
X:\CDERGUID\ for IndustrySkin Irritation and SensitizationTesting of GenericTransdermal Drug ProductsDRAFT GUIDANCEThis Guidance document is being distributed for comment purposes and suggestions regarding this draft document should be submitted within 60 days ofpublication of the Federal Register notice announcing the availability of the draft Guidance . Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration,5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with thedocket number listed in the notice of availability that publishes in the Federal questions on the content of the draft document contact Mary Fanning, 301-827-5845. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)February 1999 OGD #X:\CDERGUID\ for IndustrySkin Irritation and SensitizationTesting of GenericTransdermal Drug ProductsAdditional copies are available from:the Drug Information Branch (HFD-210),Center for Drug Evaluation and Research (CDER),5600 Fishers Lane, Rockville, MD 20857, (Tel) 301-827-4573 Internet at Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)February 1999 OGD #X:\CDERGUID\ OF for a Cumulative Skin Irritation for a Skin Sensitization Study (Modified DraizeTest).
X:\CDERGUID\2887DFT.WPD 2/5/99 Guidance for Industry Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
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