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Sopp
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#	Item
31	Creating a successful distribution business combining biocontrol and other solutions. Dr. Paul Sopp Technical Director Add to Reading List Source URL: www.abim.ch Language: English - Date: 2013-10-24 08:37:49 Organic gardening Sustainable agriculture New product development Technology Biology Biological pest control Biopesticide Biotechnology
32	SOPP[removed]: Action Package for Posting Version # 3 Effective Date: December 5, 2011 I. Purpose This Standard Operating Policy and Procedure (SOPP) serves as a guide for Center Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Pharmacology Clinical research Center for Biologics Evaluation and Research New Drug Application Biologic Portable Document Format Package insert Medicine Food and Drug Administration Pharmaceutical sciences
33	SOPP 8402: Designation of Amendments as Major Version #4 Effective Date: October 1, 2012 I. Purpose This Standard Operating Policy and Procedure (SOPP) describes the policy and procedures for Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Medicine Prescription Drug User Fee Act New Drug Application Biosimilar Food and Drug Administration Pharmaceutical sciences Pharmacology
34	SOPP 8422: Processing of Trans-BLA Submissions Version #1 Effective Date: April 18, 2011 I. Purpose The purpose of this document is to provide guidance to Center for Biologics Evaluation and Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Pharmaceutical industry Medical informatics Electronic Common Technical Document Common Technical Document Title 21 CFR Part 11 Electronic submission Center for Biologics Evaluation and Research Food and Drug Administration Medicine Research
35	SOPP[removed]: Procedures for Resubmissions of an Application or Supplement Version # 4 Effective Date: October 1, 2012 I. Purpose This Standard Operating Policy and Procedure (SOPP) describes the policies and procedures f Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Pharmaceuticals policy Prescription Drug User Fee Act Drug safety New Drug Application Biosimilar Biologic Email Food and Drug Administration Medicine Pharmaceutical sciences
36	Microsoft Word - 75A9643.doc Add to Reading List Source URL: www.fda.gov Language: English Ombudsman Sopp
37	SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments Add to Reading List Source URL: www.fda.gov Language: English
38	SOPP[removed]Appendix 2) - Intercenter Request for Consultative or Collaborative Review Form Add to Reading List Source URL: www.fda.gov Language: English Fax Internet Computing Technology Email Electronic documents
39	SOPP 8002: Procedures for the Preparation, Clearance and Issuance of Guidance Documents Version# 6 Effective Date: December 10, 2012 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Health Center for Biologics Evaluation and Research Influenza Guidance document Food and Drug Administration Medicine Clinical research
40	SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research New Drug Application Patent application Biologic License Application FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Medicine

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