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#	Item
51	SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Version # 7 Effective Date: April 25, 2013 ___________________________________________________________ Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Food law Prescription Drug User Fee Act Drug safety Center for Biologics Evaluation and Research New Drug Application Federal Food Drug and Cosmetic Act FDA Special Protocol Assessment Food and Drug Administration Medicine Pharmaceuticals policy
52	SOPP[removed]Appendix 2) - Intercenter Request for Consultative or Collaborative Review Form Add to Reading List Source URL: www.fda.gov Language: English BLA Fax Internet Computing Technology Email Electronic documents
53	Microsoft Word - Current SOPP Nov 2010 Add to Reading List Source URL: www.pcouncil.org Language: English - Date: 2014-01-24 10:59:47 U.S. Regional Fishery Management Councils Synod Quorum Community-based organizations Heights Community Council Christianity Christian theology Conservation in the United States
54	T810.01 Regulatory SOPP Template Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Blood banks Center for Biologics Evaluation and Research Influenza Medicine Clinical research Pharmaceutical sciences
55	OECD WORKING PARTY ON STATE OWNERSHIP AND PRIVATISATION PRACTICES The Working Party on State Ownership and Privatisation Practices (WP SOPP) is a policy forum created in 2001 to promote improved corporate governance of Add to Reading List Source URL: www.oecd.org Language: English - Date: 2014-07-04 15:44:53 Corporations law Management Organisation for Economic Co-operation and Development Governance Privatization Political science Business Economics Corporate governance
56	SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Health Pharmacology Drug safety Clinical trial Investigational New Drug New Drug Application Investigational Device Exemption Clinical research Research Pharmaceutical industry
57	SOPP[removed]Appendix 2: Section VII.D: Manufacturer’s Lot Release Protocols Add to Reading List Source URL: www.fda.gov
58	SOPP[removed]Appendix 3: Section VII.E: Lot Release Testing Plans Add to Reading List Source URL: www.fda.gov
59	According to the CBER Manual of Standard Operating Procedures and Policies, Regulatory - License Applications, SOPP 8404: Refu Add to Reading List Source URL: www.fda.gov Language: English AstraZeneca Health Influenza vaccines Orthomyxoviridae Flu pandemic FluMist MedImmune Influenza Immunogenicity Vaccination Vaccines Medicine
60	SOPP 8002 Appendix 2 - Draft Guidance.doc Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Vaccine Adverse Event Reporting System Adverse Event Reporting System Center for Biologics Evaluation and Research Validation Electronic Common Technical Document Postmarketing surveillance Food and Drug Administration Clinical research Research

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