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Biosimilar
Results: 639

#	Item
361	Microsoft Word - Volume 6A Chapter 4-rev[removed]FINAL.doc Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:01:12 Pharmaceutical industry Pharmacology European Medicines Agency Drug safety Validation Summary of Product Characteristics Veterinary physician Pharmacovigilance Biosimilar Clinical research Pharmaceutical sciences Research
362	Quality Challenges and Research Needs in the Generic Pharmaceutical Industry GDUFA Regulatory Science Initiatives Public Meeting June 21, 2013 Silver Spring, MD Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Excipient Packaging and labeling Biosimilar Generic drug Xcelience NIPTE Pharmaceutical sciences Pharmacology Pharmaceutical industry
363	Statement of Administration Policy on S. 3187 – Food and Drug Administration Safety and Innovation Act Add to Reading List Source URL: www.whitehouse.gov Language: English - Date: 2012-05-17 10:42:25 Pharmaceuticals policy Drugs Pharmaceutical industry Biosimilar Biotechnology Food and Drug Administration Generic drug Medical device Prescription medication Medicine Pharmaceutical sciences Pharmacology
364	Draft Legislation for Biosimilars User Fees Add to Reading List Source URL: www.fda.gov Language: English Biologic Clinical research Pharmacology Biology Biosimilar Biotechnology Drugs
365	July 1, 2014 Commissioner Margaret A. Hamburg Food and Drug Administration[removed]New Hampshire Avenue Silver Spring, MD 20993 Add to Reading List Source URL: www.gphaonline.org Language: English - Date: 2014-07-01 09:21:44 Clinical research Biosimilar Biotechnology Drugs Biologic Pharmaceutical care management association Food and Drug Administration Center for Drug Evaluation and Research Patient Protection and Affordable Care Act Medicine Health Pharmacology
366	Key Reasons for Why You Should Attend the FDA/PQRI Conference on Evolving Product Quality • Do you want to hear the latest information from high level FDA representatives about the direction they plan to take in the fu Add to Reading List Source URL: www.pqri.org Language: English - Date: 2014-06-24 08:13:46 Food and Drug Administration Clinical pharmacology Therapeutics United States Public Health Service Biosimilar Pharmaceutical industry Regulation of food and dietary supplements by the U.S. Food and Drug Administration Form FDA 483 Pharmaceutical sciences Pharmacology Clinical research
367	June 6, 2014 Margaret A. Hamburg, MD Commissioner Food and Drug Administration[removed]New Hampshire Avenue Silver Spring, MD 20993 Add to Reading List Source URL: www.gphaonline.org Language: English - Date: 2014-07-01 09:25:57 Food and Drug Administration Pharmacy Center for Drug Evaluation and Research United States Department of Health and Human Services National Council for Prescription Drug Programs Biologic Biosimilar Trastuzumab SCRIPT Pharmaceutical sciences Medicine Pharmacology
368	Food and Drug Administration FY 2013 CJ All Purpose Table - Total Program Level Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Prescription Drug User Fee Act Priority review voucher Biosimilar Fee Generic drug Pharmaceuticals policy Pharmaceutical sciences Pharmacology
369	Food and Drug Administration FY 2013 CJ All Purpose Table - User Fees (Dollars in Thousands) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceuticals policy Drugs Prescription Drug User Fee Act Priority review voucher Office of Regulatory Affairs Animal drugs Biosimilar Family Smoking Prevention and Tobacco Control Act Food and Drug Administration Medicine Health
370	FDA FY 2013 Budget Protecting Patients Budget Authority: +$25,148,[removed]3FTE Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Pharmaceuticals policy Therapeutics Biosimilar Generic drug New Drug Application Center for Drug Evaluation and Research Biologic Pharmaceutical sciences Food and Drug Administration Pharmacology

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