Biosimilar

Results: 639



#Item
271Food and Drug Administration / Food and Drug Administration Amendments Act / Food law / Pharmaceutical industry / Biosimilar / Crizotinib / Denosumab / New Drug Application / Anaplastic lymphoma kinase / Chemistry / Pharmacology / Pharmaceutical sciences

Microsoft Word - PedsODAC Backgrounder[removed]doc

Add to Reading List

Source URL: www.fda.gov

Language: English
272Clinical research / Pharmaceutical industry / Food and Drug Administration / Biotechnology / Biosimilar / Biologic / Validation / Pharmacokinetics / New Drug Application / Pharmaceutical sciences / Pharmacology / Medicine

Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

Add to Reading List

Source URL: www.fda.gov.

Language: English
273Clinical pharmacology / Food and Drug Administration / Therapeutics / United States Public Health Service / Biosimilar / Biologic / Pharmacology / Clinical research / Pharmaceutical sciences

FY 2013 BsUFA Financial Report

Add to Reading List

Source URL: www.fda.gov

Language: English
274Pharmaceutical industry / Biotechnology / Pharmaceuticals policy / Biosimilar / Drugs / Drug Price Competition and Patent Term Restoration Act / Biologic / Food and Drug Administration / Generic drug / Pharmaceutical sciences / Pharmacology / Clinical research

    Faculty Publications  UC Hastings College of the Law Library   

Add to Reading List

Source URL: librarysource.uchastings.edu

Language: English - Date: 2013-06-19 19:19:05
275Biosimilar / Biotechnology / Drugs / Food and Drug Administration / Biologic / Pharmaceutical industry / Etanercept / Center for Drug Evaluation and Research / Fob / Pharmacology / Pharmaceutical sciences / Clinical research

Lost and Confused Signpost

Add to Reading List

Source URL: www.goldstandard.com

Language: English - Date: 2013-02-07 18:03:06
276Medicine / Clinical research / Biosimilar / Biotechnology / Clinical pharmacology / Biologic / Medical prescription / Prescription medication / CalPERS / Pharmacology / Pharmaceutical sciences / Drugs

PDF Document

Add to Reading List

Source URL: freepdfhosting.com

Language: English - Date: 2013-08-23 18:02:35
277Pharmaceutical sciences / Biosimilar / Biologic / Pharmaceutical industry / Pharmacy / Food and Drug Administration / Patient safety / Actavis / Adverse effect / Medicine / Pharmacology / Health

Paul M. Bisaro President & CEO T[removed]Actavis, Inc.

Add to Reading List

Source URL: freepdfhosting.com

Language: English - Date: 2013-08-22 10:47:08
278Biosimilar / Biotechnology / Drugs / Food and Drug Administration / Biologic / FDA Special Protocol Assessment / Pharmacology / Clinical research / Pharmaceutical sciences

FY 2013 BsUFA Financial Report

Add to Reading List

Source URL: www.fda.gov

Language: English
279Drugs / Pharmaceuticals policy / Clinical pharmacology / Biosimilar / Biotechnology / Biologic / Generic drug / Food and Drug Administration / Prescription medication / Pharmacology / Pharmaceutical sciences / Clinical research

Board of Administration Agenda Template 3

Add to Reading List

Source URL: www.gphaonline.org

Language: English - Date: 2013-08-21 14:12:53
280Pharmaceutical industry / Drug discovery / Food and Drug Administration / Biosimilar / Pre-clinical development / Clinical trial / Biologic / Immunogenicity / Bioequivalence / Pharmaceutical sciences / Pharmacology / Clinical research

September 13,2004 Enclosed, please find the document submitted by Dr. James Green of Biogen Idec for the Docket No. 2004N-0355/Scientific Considerations Related to Developing Follow-Biologics Protein Products.

Add to Reading List

Source URL: www.fda.gov

Language: English - Date: 2006-04-25 18:26:37
UPDATE