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Nr.	Title
3200	Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3201	Guidance for Industry and FDA Review Staff Collection of Platelets by Automated Methods
3203	Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3204	FEDERAL REGISTER 21 CFR Part 866 [Docket No. 2007N–0294] Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
3205	Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
3207	Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
3208	Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3209	FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule
3212	Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide
3213	Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
3214	FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule
3215	Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
3235	NOTICE TO APPLICANTS Volume 6A VETERINARY MEDICINAL PRODUCTS General Information
3236	NOTICE TO APPLICANTS Volume 6C GUIDELINE ON THE PACKAGING INFORMATION OF VETERINARY MEDICINAL PRODUCTS AUTHORISED BY THE COMMUNITY
3237	Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
3238	Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
3240	Marketed Unapproved Drugs
3241	PET Drug Products - CGMP / Small Entities
3242	Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
3284	Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC
3285	Guidance for the communication on GCP inspections and findings
3286	Guidance for the conduct of GCP inspections
3287	Annex I TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Investigator site
3288	Annex II TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Clinical Laboratories
3289	Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems
3290	Annex IV TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Sponsor and CRO
3291	Guidance for the preparation of GCP inspections
3292	Guidance for the preparation of Good Clinical Practice inspection reports
3293	Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products
3295	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
3296	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 1 Residue on Ignition/Sulphated Ash General Chapter
3298	Indexing Structured Product Labeling
3299	Current Good Manufacturing Practice for Phase 1 Investigational Drugs
3300	Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
3301	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3302	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3303	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3304	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 5: Disintegration Test General Chapter
3305	2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 - 34).
3306	Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)
3310	Q4B Annex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5
3325	COMPLIANCE POLICY GUIDE Sec. 410.100 Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations (CPG 7132a.06)
3326	Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
3327	Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
3331	Annex 1 - Contract between Auditor and the API Compliance Institute
3332	Annex 2 - Agreement on Audit Execution
3333	Annex 3 - Secrecy Agreement
3335	Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder
3336	Standardised Letters related to Shared 3rd Party Audits: Letter 2 - Letter to the API Manufacturer
3337	Standardised Letters related to Shared 3rd Party Audits: Letter 3 - Letter from the API Manufacturer to the customer
3338	Annex 5 - Feedback Form
3339	APIC - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005
3350	Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
3353	Process Validation: General Principles and Practices
3355	2008/C 243/09 Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies (Official Journal C 243/1, 2008)
3356	Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
3357	Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
3358	Recommendation on inspection procedures for the verification of good clinical practice compliance
3359	Procedure for standardisation of GCP inspection entries in EudraCT
3360	Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice
3361	Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95)
3375	Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information
3376	Residual Solvents in Drug Products Marketed in the United States
3377	Q8(R2) Pharmaceutical Development Revision 2
3382	Annex 11: Computerised Systems
3384	Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
3386	Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review
3399	Q4B Annex 2(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
3400	Q4B Annex 3(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
3401	Q4B Annex 4A(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3402	Q4B Annex 4B(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3403	Q4B Annex 4C(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3404	Q4B Annex 6(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter
3405	Q4B Annex 7(R2): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter
3406	Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter
3407	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - General
3408	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Equipment
3409	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Control of Components and Drug Product Containers and Closures
3410	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Packaging and Labeling Control
3411	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Laboratory Controls
3412	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Records and Reports
3413	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Production and Process Control
3426	Guideline on Active Substance Master File Procedure (CPMP/QWP/ 227/02 Rev. 2)
3427	Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97 Rev. 1)
3428	Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02 Rev. 1)
3429	Guideline on the Chemistry of New Active Substances (CPMP/QWP/130/96 Rev. 1)
3430	Investigation of Chiral Active Substances (3CC29A)
3431	Chemistry of Active Substances (3AQ5A)
3433	Process Validation (CPMP/QWP/848/96)
3434	Annex II to Note for Guidance on Process Validation: - Non-Standard Processes (CPMP/QWP/2054/03)
3435	Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products (CPMP/QWP/159/01)
3436	Note for Guidance on Manufacture of the Finished Dosage Form (CPMP/QWP/486/95)
3437	Annex to Note for Guidance on Manufacture of the finished dosage Form: Start of Shelf-Life of the Finished Dosage Form (CPMP/QWP/072/96)
3438	The use of Ionizing Radiation in the Manufacture of Medicinal Products 3AQ4A
3440	Guideline on the Limits of genotoxic impurities (CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006)
3441	Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
3442	Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99)
3443	Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99)
3444	ICH Topic Q3C (R5) Impurities: Guideline for residual solvents
3445	Annexes to: CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents & CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents; ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES; ANNEX II: RESIDUES OF SOLVENTS USED IN THE MANUFACTURE OF FINISHED PRODUCTS
3447	Guideline on setting specifications for related impurities in antibiotics EMA/CHMP/CVMP/QWP/199250/2009
3448	ICH Topic Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
3449	ICH Topic Q4B Annex 1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
3450	ICH Topic Q4B Annex 2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
3451	ICH Topic Q4B Annex 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
3452	ICH Topic Q4B Annex 4 A Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3453	ICH Topic Q4B Annex 4 B Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3454	ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3455	ICH Topic Q4B Annex 5 Disintegration Test General Chapter
3456	Guideline on the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations
3457	Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations
3458	Parametric Release CHMP/QWP/569959/2008
3460	Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A) CPMP/ICH/ 367/96-ICH Q6A
3461	Validation of Analytical Procedures: Text and Methodology (ICH Q2) CPMP/ICH/381/95 - ICH Q2 (R1)
3462	Specifications and control Tests on the Finished Product 3AQ11A
3464	Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
3466	VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use
3467	Quality of Water for Pharmaceutical Use CPMP/QWP/ 158/01 Rev. 1
3468	Reflection Paper on Water for Injection prepared by Reverse Osmosis CHMP/CVMP/28271/08
3469	Note for Guidance: Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products CPMP/CVMP/QWP /115/95
3474	Stability Testing for Applications for Variations to a Marketing Authorisation CPMP/QWP/576/96 Rev 1
3475	Stability Testing of New Drug Substances and Drug Products (ICH Q1A) CPMP/ICH/ 2736/99-ICH Q1A (R2)
3476	Stability Testing of Existing Active Ingredients and Related Finished Products CPMP/QWP/ 122/02 Rev. 1 corr
3477	Annex: Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances CPMP/QWP/ 609/96 Rev. 2
3478	Evaluation of Stability Data (ICH Q1E) CPMP/ICH/ 420/02-ICH Q1E
3479	Stability Data Package for Registration in Climatic Zones III and IV (ICH Q1F) CPMP/ICH/ 421/02-ICH Q1F
3480	Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products (ICH Q1D) CPMP/ICH/ 4104/00-ICH Q1D
3481	In-Use Stability Testing of Human Medicinal Products CPMP/QWP/2934/99
3482	Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution CPMP/QWP/ 159/96 Corr.
3483	Photostability Testing of New Active Substances and Medicinal Products (ICH Q1B) CPMP/ICH/279/95-ICH Q1B
3484	Stability Testing: Requirements for New Dosage Forms (ICH Q1C) CPMP/ICH/ 280/95-ICH Q1C
3486	CONCEPT PAPER ON THE DEVELOPMENT OF A QUALITY GUIDELINE ON PHARMACEUTICAL DEVELOPMENT OF MEDICINES FOR PAEDIATRIC USE
3487	ICH Topic Q 8 (R2)Pharmaceutical Development NOTE FOR GUIDANCE ON PHARMACEUTICAL DEVELOPMENT
3489	Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1
3490	NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
3492	Note for Guidance on Development Pharmaceutics CPMP/QWP/155/96
3494	Medicinal Gases: Pharmaceutical Documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) (CPMP/QWP/1719/00)
3495	Specification Limits for Residues of Metal Catalysts (EMEA/CHMP/SWP/4446/2000)
3496	Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials (CHMP/QWP/185401/2004)
3497	Radiopharmaceuticals Based on Monoclonal Antibodies (3AQ21A)
3498	Pharmaceutical Quality of Inhalation and Nasal Products
3499	Radiopharmaceuticals (3AQ20A)
3500	Suitability of the Graduation of Delivery Devices for Liquid Dosage Forms (CHMP/QWP/178621/05)
3501	Development of CHMP Guideline on Dosing Delivery of Injectable Liquids (CHMP/QWP/1888/04)
3502	Quality of Modified Release Products A) Oral Solid Dosage Forms B) Transdermal Dosage Forms Section I (Quality) CPMP/QWP/ 604/96
3503	Radiopharmaceuticals
3505	Questions & answers (Q&A) on quality of herbal medicinal products / traditional herbal medicinal products
3506	Level of purification of extracts to be considered as herbal preparations EMEA/HMPC/186645/2008
3507	Development of a guideline on preparation on herbal teas EMEA/HMCP/451978/08
3508	Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products EMEA/HMPC/253629/07
3509	Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products EMEA/HMPC/CHMP/CVMP/287539/05 Rev. 1
3510	Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products EMEA/HMPC/CHMP/CVMP/214869/06
3511	The use of Fumigants EMEA/HMPC/125562/06
3512	Good Agricultural and Collection Practice for starting materials of Herbal Origin EMEA/HMPC/246816/05
3513	Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products CPMP/QWP/2819/00 Rev. 2
3515	APIC Quick Guide for API Sourcing, 2008
3517	AIDE-MEMOIRE on GMP INSPECTION RELATED TO PACKAGING (PI 028-1)
3518	Aide Memoire on INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS (PI 030-1)
3519	Guideline on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for News Submissions and Variations
3527	Corrigendum to Decision No 1/2003 (2003/128/EC) of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement (OJ L 56 of 1.3.2003)
3528	EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
3530	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 7: Dissolution Test General Chapter
3531	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 8: Sterility Test General Chapter
3532	M2 eCTD: Electronic Common Technical Document Specification
3533	M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
3534	M5 Data Elements and Standards for Drug Dictionaries
3535	Submitting Marketing Applications According to the ICH-CTD Format — General Considerations
3538	Container Closure Systems for Packaging Human Drugs and Biologics - Questions and Answers
3541	21 CFR Part 210 Current Good Manufacturing Practice
3542	Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products 3/2009
3544	COMPLIANCE POLICY GUIDE Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b) (CPG 7132a.03)
3545	COMPLIANCE POLICY GUIDE Sec. 420.200 Compendium Revisions and Deletions (CPG 7132.02)
3547	COMPLIANCE POLICY GUIDE Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial Products (CPG 7132.05)
3548	COMPLIANCE POLICY GUIDE Sec. 420.500 Interference with Compendial Tests (CPG 7132a.01)
3549	COMPLIANCE POLICY GUIDE Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software (CPG 7132a.17)
3550	COMPLIANCE POLICY GUIDE Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
3551	COMPLIANCE POLICY GUIDE Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)
3552	COMPLIANCE POLICY GUIDE Sec. 425.400 Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)
3553	COMPLIANCE POLICY GUIDE Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records (CPG 7132a.08)
3554	COMPLIANCE POLICY GUIDE Sec. 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms (CPG 7132b.10)
3555	COMPLIANCE POLICY GUIDE Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs (CPG 7132.13)
3556	COMPLIANCE POLICY GUIDE Sec. 430.300 Labeling Shipping Containers of Drugs (CPG 7132b.13)
3557	COMPLIANCE POLICY GUIDE Sec. 440.100 Marketed New Drugs Without Approved NDAs (CPG 7132c.02)
3558	COMPLIANCE POLICY GUIDE Sec. 442.100 New Drugs - Export (CPG 7132c.01)
3559	COMPLIANCE POLICY GUIDE Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (CPG 7132c.05)
3560	COMPLIANCE POLICY GUIDE Sec. 446.100 Regulatory Action Regarding Approved New Drug and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (CPG 7132c.06)
3561	COMPLIANCE POLICY GUIDE Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs (CPG 7132c.03)
3562	COMPLIANCE POLICY GUIDE Sec. 450.100 CGMP Enforcement Policy - OTC vs Rx Drugs (CPG 7132.10)
3563	COMPLIANCE POLICY GUIDE Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products
3564	COMPLIANCE POLICY GUIDE Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packing of Over-the-Counter Drug Products
3565	COMPLIANCE POLICY GUIDE Sec. 490.200 Parametric Release - Parenteral Drug Products Terminally Sterilized by Moist Heat
3567	COMPLIANCE POLICY GUIDE Sec. 470.100 Orders for Post-Approval Record Reviews
3568	COMPLIANCE POLICY GUIDE Sec. 480.100 Requirements for Expiration Dating and Stability Testing (CPG 7132a.04)
3569	COMPLIANCE POLICY GUIDE Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs (CPG 7132b.11)
3570	COMPLIANCE POLICY GUIDE Sec. 480.300 Lack of Expiration Date of Stability Data (CPG 7132a.10)
3587	2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (Official Journal L 81, 20/3/2008, p. 51 - 52 ).
3589	Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures
3590	Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC
3591	Questions & Answers Document - Version 10
3592	Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006 (February 2009)