Center for Drug Evaluation and Research

Results: 4314



#Item
11Pharmaceutical industry / Biotechnology / Drugs / Pharmacy / Biopharmaceutical / Biosimilar / Pharmaceutical drug / Generic drug / In vitro / Center for Drug Evaluation and Research

ATTORNEY LISTINGS Advisory Judicial Review (Dispute Litigation)

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Source URL: www.managingip.com

Language: English - Date: 2015-09-23 06:20:11
12Food and Drug Administration / Pharmaceutical industry / Pharmaceuticals policy / Food law / Abbreviated New Drug Application / New drug application / Federal Food /  Drug /  and Cosmetic Act / Generic drug / Approved Drug Products with Therapeutic Equivalence Evaluations / Center for Drug Evaluation and Research / Drug Master File

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry

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Source URL: www.fda.gov

Language: English
13Biotechnology / Pharmaceutical industry / Drugs / Pharmacy / Food and Drug Administration / Biopharmaceutical / Biosimilar / Medical device / Center for Drug Evaluation and Research / Pharmaceutical drug

FIRM LOCATION David G Adams

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Source URL: www.managingip.com

Language: English - Date: 2015-09-23 06:24:09
14Medicinal chemistry / Drug discovery / Cheminformatics / Computational chemistry / Quantitative structureactivity relationship / Machine learning / Structureactivity relationship / Test set / Salmonella / Applicability domain

Characterizing the Domain of QSAR Models Predicting Genotoxicity Kevin P. Cross1, Lidiya Stavitskaya2, R. Daniel Benz2*, Naomi L. Kruhlak2 1Leadscope, Inc., Columbus, OH; 2FDA Center for Drug Evaluation and Research, Sil

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Source URL: www.leadscope.com

Language: English - Date: 2015-11-13 06:28:16
15Pharmaceuticals policy / Drugs / Pharmaceutical industry / Clinical pharmacology / Over-the-counter drug / Medical prescription / Prescription drug / Pharmaceutical drug / Generic drug / Tablet / Food and Drug Administration / Center for Drug Evaluation and Research

DOC Document

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Source URL: www.nc-net.info

Language: English - Date: 2014-12-24 15:18:44
16Food and Drug Administration / Medicine / Stem cells / Health care / Biology / Transplantation medicine / Good tissue practice / Allotransplantation / Blood / Center for Biologics Evaluation and Research / Cord blood / Tissue

Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products Draft Guidance for Industry and FDA Staff

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Source URL: www.fda.gov

Language: English
17Health care / Health / Medicine / Food and Drug Administration / Euphoriants / Pharmaceuticals policy / Drug safety / Eli Lilly and Company / Pharmacovigilance / Opioid / Center for Drug Evaluation and Research / Methadone

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. This content has not been altered or updated since it was archived

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Source URL: www.supportprop.org

Language: English - Date: 2015-05-04 15:12:59
18Pharmaceutical industry / Food and Drug Administration / Biosimilar / Biotechnology / Drugs / Biologic / Generic drug / Center for Biologics Evaluation and Research / European Medicines Agency / Pharmaceutical sciences / Pharmacology / Clinical research

Microsoft Word - GHLF 50 State Network Biosims Brief TPs FINAL.docx

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Source URL: www.50statenetwork.org

Language: English - Date: 2015-02-07 13:27:50
19Pharmacology / Pharmaceutical industry / Biosimilar / Biotechnology / Drugs / Food and Drug Administration / Biologic / Center for Biologics Evaluation and Research / Generic drug / Medicine / Pharmaceutical sciences / Health

  Global  Healthy  Living  Foundation   515  North  Midland  Avenue   Upper  Nyack,  New  York  10960  USA   +1  845  348  0400  

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Source URL: www.50statenetwork.org

Language: English - Date: 2015-02-07 13:27:49
20Biotechnology / Food and Drug Administration / Childbirth / Blood banks / Cord blood bank / Transplantation medicine / Cord blood / Current Good Tissue Practices / Center for Biologics Evaluation and Research / Biology / Medicine / Stem cells

Guidance for Industry Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications

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Source URL: www.fda.gov

Language: English
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