Guidance for Industry ECA Academy（指导行业ECA学院）.PDF

Guidance for Industry SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 the docket number listed in the notice of availability that publishes in the Federal Register. For questions on the content of the draft document contact Nancy Sager, 301-594-5633 (CDER). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 1998 CMC # X:\CDERGUID\1722DFT.WPD 12/11/98 Guidance for Industry SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum Additional 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 /cder/guidance/index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 1998 CMC xx X:\CDERGUID\1722DFT.WPD 12/11/98