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Displaying 1-7 of 7 results for author "United States. Food and Drug Administration. Office of Regulatory Affairs."
Evidence and proof.
- Text
- [Rockville, Md.?] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Regulatory Affairs, 1985.
- 1985
- 1 Item
Item details Format Call Number Item Location Book/Text JLF 88-1635 Offsite Guidance for industry : standards for securing the drug supply chain : standardized numerical identification for prescription drug packages.
- Text
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER) : Office of Regulatory Affairs, [2009]
- 2009
- 1 Resource
Available Online
https://purl.fdlp.gov/GPO/LPS110476Guidance for industry : CGMP for phase 1 investigational drugs.
- Text
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Office of Regulatory Affairs, [2008]
- 2008
- 1 Resource
Available Online
https://purl.fdlp.gov/GPO/LPS111655Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms.
- Text
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001]
- 2001
- 1 Resource
Available Online
https://purl.fdlp.gov/GPO/LPS115334Evidence and proof.
- Text
- [Rockville, Md.?] : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Regulatory Affairs, 1985.
- 1985
- 1 Item
Item details Format Call Number Item Location Text HE 20.4002:Ev 3 Off-site Guideline on sterile drug products produced by aseptic processing / prepared by Center for Drugs and Biologics and Office of Regulatory Affairs, Food and Drug Administration.
- Text
- Rockville, Md. : U.S. Department of Health and Human Services Public Health Service, Food and Drug Administration, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:St 4 Off-site Evidence and proof.
- Text
- [Rockville, Md.?] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Regulatory Affairs, 1985.
- 1985
- 1 Item
Item details Format Call Number Item Location Book/Text HE 20.4002:Ev 3 Off-site
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