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  • FDA Medical Library serials holdings list / prepared by Sylvia A. Bullock, Wendy W. Cheng.

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, 1995.
    • 1995
    • 1 Item
    FormatCall NumberItem Location
    Text JBF 96-976Offsite

  • 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/LPS1445

  • Radiation dose estimates for radiopharmaceuticals [microform] / prepared by M.G. Stabin, J.B. Stubbs, R.E. Toohey.

    • Text
    • Washington, DC : Division of Industrial and Medical Nuclear Safety, 1996.
    • 1996

  • Guideline for industry [microform] : for the submission of an environmental assessment in human drug applications and supplements.

    • Text
    • [Rockville, Md.?] : Center for Drug Evaluation and Research, [1995]
    • 1995

  • Guidance for industry [microform] : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

    • Text
    • [Rockville, MD] : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1995]
    • 1995

  • Guidance for industry : clinical pharmacology section of labeling for human prescription drug and biological products : content and format.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110438

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110532

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110544

  • Está enfermo uno de sus hijos? : No adivine. Lea las indicaciones.

    • Text
    • [Rockville, MD] : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS109931

  • Frecuentes preguntas acerca de las drogas genéricas.

    • Text
    • [Rockville, Md.] : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, [2004]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS109938

  • 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/LPS110476

  • Guidance for industry : animal models : essential elements to address efficacy under the animal rule.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110484

  • Guidance for industry : cooperative manufacturing arrangements for licensed biologics.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research ; Silver Spring, MD : Center for Drug Evaluation and Research.
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110585

  • Guidance for industry : contents of a complete submission for the evaluation of proprietary names.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110589

  • Guidance for industry : process validation, general principles and practices.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110592

  • Guidance for industry : tropical disease priority review vouchers.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110607

  • Piénselo muy bien : una guía para el control de los beneficios y riesgos de las medicinas.

    • Text
    • [Rockville, Md.?] : Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS109971

  • Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; [Rockville, MD] : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111012

  • Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.

    • 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, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111793

  • Animal models : essential elements to address efficacy under the animal rule.

    • 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], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111021

  • E2f development safety update report.

    • Text
    • [Silver Spring, MD] : [Center for Drug Evaluation and Research] ; [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111600

  • Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner : Center for Devices and Radiological Health (CDRH) : Center for Drug Evaluation and Research (CDER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111001

  • Guidance for industry : integrated summary of effectiveness.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111186

  • Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.

    • Text
    • Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111634

  • Guidance 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/LPS111655

  • Guidance for industry : indexing structured product labeling.

    • 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, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111789

  • Guidance for industry : Q3A impurities in new drug substances.

    • Text
    • Sliver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111818

  • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.

    • Text
    • [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111169

  • Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter.

    • Text
    • [Silver Spring, MD] : [Center for Drug Evaluation and Research] ; [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111591

  • Guidance for industry : label comprehension studies for nonprescription drug products : draft guidance.

    • Text
    • [Beltsville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112207

  • Guidance for industry : submission of summary bioequivalence data for ANDAs.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112216

  • Guidance for industry : community-acquired bacterial pneumonia : developing drugs for treatment.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112221

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 1. Residue on ignition/sulphated ash general chapter.

    • 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, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112496

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 2. Test for extractable volume of parenteral preparations general chapter.

    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112501

  • Guidance for industry : FDA export certificates.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Veterinary Medicine : Center for Food Safety and Applied Nutrition, [2005]
    • 2005
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113005

  • Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 5. Disintegration test general chapter.

    • Text
    • [College Park, Md.?] : [Center for Drug Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112523

  • Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111907

  • Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111964

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111972

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111974

  • Guidance for industry : Q8 pharceutical development.

    • 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, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112066

  • Guidance for industry : integrated summaries of effectiveness and safety : location within the common technical document.

    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112211

  • Guidance for industry : Q10 pharmaceutical quality system.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112219

  • Guidance for industry : influenza, developing drugs for treatment and/or prophylaxis.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112225

  • Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.

    • 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, [2007]
    • 2007
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112256

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.

    • 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, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112494

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 3. Test for particulate contamination : subdivisible particles general chapter.

    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112504

  • Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [2006]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112510

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4A. Microbiological examination of nonsterile products : microbial enumeration tests general chapter.

    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112508

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4B. Microbiological examination of nonsterile products : tests for specified microorganisms general chapter.

    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112512

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