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  • Proceedings of the Sixth International Symposium on Pertussis : [microform] / Sponsored by Center for Biologics Evaluation and Research, Jack Masur Auditorium, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, September 26-28, 1990.

    • Text
    • Bethesda, Md. : Dept. of Health and Human Services, U.S. Public Health Service, Food and Drug Administration, 1990.
    • 1990

  • 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

  • Assay migration studies for in vitro diagnostic devices.

    • Text
    • [Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety ; Rockville, MD : Center for Biologics Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110552

  • 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

  • Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter.

    • Text
    • [Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110450

  • 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

  • User fees and refunds for premarket approval applications.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS110430

  • 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

  • Guidance for industry : potency tests for cellular and gene therapy products.

    • Text
    • [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/LPS110622

  • Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter.

    • Text
    • [Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110454

  • Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.

    • Text
    • [Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110458

  • S9 nonclinical evaluation for anticancer pharmaceuticals.

    • Text
    • [Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110465

  • Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS110580

  • PDUFA pilot project : proprietary name review.

    • Text
    • [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/LPS110633

  • 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 : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency.

    • Text
    • 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/LPS111654

  • 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

  • Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS111189

  • 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 : general principles for the development of vaccines to protect against global infectious diseases.

    • Text
    • 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/LPS111025

  • 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 : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.

    • Text
    • 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/LPS111638

  • 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 : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.

    • 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/LPS111798

  • 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

  • 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 and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS111915

  • Guidance for industry : considerations for plasmid DNA vaccines for infectious disease indications.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2007]
    • 2007
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112199

  • Guidance for industry : informed consent recommendations for source plasma donors participating in plasmapheresis and immunization programs.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2007]
    • 2007
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112432

  • Guidance for industry : minimally manipulated, unrelated, allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution in patients with hematological malignancies.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS112475

  • 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 : implementation of acceptable full-length donor history questionnaire and accompanying materials for use in screening donors of 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, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112499

  • Guidance for industry : nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV), testing, product disposition, and donor deferral and reentry.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS112841

  • 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

  • Guidance for industry : recommendations for deferral of donors and quarantine and retrieval of blood and blood products in recent recipients of smallpox vaccine (vaccinia virus) and certain contacts of smallpox vaccine recipients.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2002]
    • 2002
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113069

  • Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001]
    • 2001
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113193

  • Annual reports for approved premarket approval applications (PMA).

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS112503

  • Bundling multiple devices or multiple indications in a single submission.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2007]
    • 2007
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112429

  • FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS113026

  • FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals.

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

    Available Online

    https://purl.fdlp.gov/GPO/LPS113041

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