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Displaying 1-19 of 19 results for author "Center for Drugs and Biologics (U.S.)"
Approved drug products with therapeutic equivalence evaluations [microform].
- Text
- [Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : [For sale by the Supt. of Docs., U.S. G.P.O., 1985-
- 1985-present
- 1 Resource
Available Online
http://purl.access.gpo.gov/GPO/LPS1445Compliance program reference : inspections of licensed and unlicensed blood banks (compliance program #7342.001) and inspections of source plasma establishments (compliance program #7342.002).
- Text
- [Rockville, MD] : Center for Drugs and Biologics, [1985]
- 1985
- 1 Item
Item details Format Call Number Item Location Book/Text JBF 12-465 Schwarzman Building - General Research Room 315 Available - Can be used on site. Please visit New York Public Library - Schwarzman Building to submit a request in person.
Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, [1987]
- 1987
- 1 Resource
Available Online
https://purl.fdlp.gov/GPO/LPS119821Approved drug products with therapeutic equivalence evaluations.
- Text
- [Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics
- 1985-present
- 2 Resources
Available Online
See All Available Online Resources
Compliance program reference : otc drug monograph implementation (compliance program #7361.003).
- Text
- [Rockville, Md.] : Center for Drugs and Biologics, [1985]
- 1985
- 1 Item
Item details Format Call Number Item Location Text HE 20.4202:C 73 Off-site Compliance program reference : inspections of licensed and unlicensed blood banks (compliance program #7342.001) and inspections of source plasma establishments (compliance program #7342.002).
- Text
- [Rockville, MD] : Center for Drugs and Biologics, [1985]
- 1985
- 1 Item
Item details Format Call Number Item Location Text HE 20.4202:C 73/2 Off-site Guideline on formatting, assembling, and submitting new drug and antibiotic applications.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:An 8/2 Off-site Guideline for the format and content of the chemistry, manufacturing, and controls section of an application.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:C 42 Off-site Guideline for the format and content of the human pharmacokinetics and bioavailability section of an application.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:H 88/3 Off-site Guideline for the submission in microfiche of the archival copy of an application.
- Text
- Rockville, MD : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:Ar 2 Off-site Guideline for submitting documentation for the manufacture of and controls for drug products.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:M 31/2 Off-site Guideline for submitting samples and analytical data for methods validation.
- Text
- Rockville, Md. : Food and Drug Administration, Center for Drugs and Biologics, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:M 56 Off-site Guideline for submitting documentation for the stability of human drugs and biologics.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:H 88 Off-site Guideline for the format and content of the microbiology section of an application.
- Text
- Rockville, MD : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:M 58 Off-site Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application.
- Text
- Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services, 1987.
- 1987
- 1 Item
Item details Format Call Number Item Location Text HE 20.4208:N 73 Off-site Guideline for submitting documentation for packaging for human drugs and biologics / Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services.
- 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:H 88/2 Off-site Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances / Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services.
- 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:M 31 Off-site Guideline on general principles of process validation / prepared by Center for Drugs and Biologics and Center for Devices and Radiological Health, 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:P 94 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
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