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Biologic license application
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81	sroberts on DSK5SPTVN1PROD with NOTICES[removed]Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Pharmaceutical sciences Biosimilar New Drug Application Biologic License Application Investigational New Drug Center for Biologics Evaluation and Research Structured Product Labeling Title 21 CFR Part 11 Food and Drug Administration Medicine Health
82	Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices manufactured, processed, packed, or held).1 All product applications should contain a complete and thorough Chemistry, Manufacturing, and Contro Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Health Research Clinical research Pharmacology Pharmaceutical industry Biosimilar New Drug Application Biologic License Application Investigational New Drug Food and Drug Administration Medicine Drug safety
83	GUIDANCE FOR SPONSORS, INDUSTRY, RESEARCHERS, INVESTIGATORS, AND FOOD AND DRUG ADMINISTRATION STAFF Add to Reading List Source URL: www.fda.gov Language: English - Date: 2009-01-21 15:59:27 Research Investigational New Drug New Drug Application ClinicalTrials.gov Federal Food Drug and Cosmetic Act Biologic License Application Drug Price Competition and Patent Term Restoration Act Prescription Drug User Fee Act Food and Drug Administration Medicine Health
84	Microsoft Word - 9255dft_[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Center for Biologics Evaluation and Research Investigational New Drug New Drug Application Federal Food Drug and Cosmetic Act Biologic License Application Medical device Title 21 CFR Part 11 Food and Drug Administration Medicine Health
85	REVISED Guidance Providing Regulatory Submissions to CBER in Electronic Format Add to Reading List Source URL: www.fda.gov Language: English Knowledge Center for Biologics Evaluation and Research Submission management Investigational New Drug New Drug Application Electronic submission Biologic License Application Portable Document Format Biologic Food and Drug Administration Medicine Health
86	DATE SUBMITTED TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR[removed]) Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Therapeutics United States Public Health Service Paperwork Reduction Act Electronic Common Technical Document Biologic License Application New Drug Application Food and Drug Administration Clinical research Research
87	INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE (The field numbers below correspond to the numbered boxes on the Form FDA 356h) NOTE: Please su Add to Reading List Source URL: www.fda.gov Language: English Medicine Drug safety Health Clinical research New Drug Application Investigational New Drug Biologic License Application Drug Master File Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
88	Federal Register / Vol. 71, No[removed]Tuesday, October 17, [removed]Notices information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of aut Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences New Drug Application Debarment Biologic License Application Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
89	PDF Document Add to Reading List Source URL: media.wiley.com Language: English - Date: 2008-10-16 05:02:06 Health Biosimilar Center for Biologics Evaluation and Research Biologic License Application Biologic Center for Drug Evaluation and Research Biopharmaceutical Adverse Event Reporting System Validation Food and Drug Administration Pharmaceutical sciences Medicine
90	Guidance for Industry and FDA Staff: Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences New Drug Application Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Biologic License Application Investigational New Drug Title 21 of the Code of Federal Regulations Investigational Device Exemption Food and Drug Administration Medicine Health