USFDA Guidelines for Pharmaceuticals

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     Category                  Title     Type      Date
Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures Draft Guidance 03/30/15
Draft Guidance for Industry and FDA Staff : Current Good Manufacturing Practice Requirements For Combination Products Current Good Manufacturing Practice Requirements For Combination Products Draft Guidance 01/27/15
Pharmaceutical Quality/CMC SUPAC: Manufacturing Equipment Addendum Final Guidance 12/01/14
Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Product Q&A Final Guidance 05/14/14
Current Good Manufacturing Practices (cGMPs) Heparin for Drug and Medical Device Use : Monitoring Crude Heparin for Quality Final Guidance 06/25/13
Current Good Manufacturing Practices (cGMPs) Non-Penicillin Beta Lactam Risk Assessment : A cGMP Framework Final Guidance 04/17/13
Current Good Manufacturing Practices (cGMPs)/Compliance Guidance for Industry : Organ Specific Warnings: Internal Analgesic, Antipyretic and Ant rheumatic Drug Products for Over-the-Counter Human Use-Labeling Draft Guidance 07/03/12
Current Good Manufacturing Practices (cGMPs)/Compliance Guidance for Industry: Pyrogen and Endotoxins Testing : Q&A Final Guidance 06/28/12
Current Good Manufacturing Practices (cGMPs)/Compliance Media Fills for Validation of Aseptic preparations for Positron Emission Tomography Final Guidance 04/10/12
Current Good Manufacturing Practices (cGMPs)/Compliance Q&A on Current Good Manufacturing Practices (cGMPs) for Drug Final Guidance 12/21/11
Current Good Manufacturing Practices (cGMPs)/Compliance Marketed Unapproved Drugs-Compliance Policy Guide  Final Guidance  09/191/1
 Current Good Manufacturing Practices (cGMPs)/Compliance and Small Entity Compliance Guide PET Drugs Current Good Manufacturing Practice (CGMP): Small Entity Compliance Guide Final Guidance 08/04/11
Current Good Manufacturing Practices (cGMPs)/Compliance Dosage Delivery Devices for Quality Ingested OTC Liquid Drug Products Final Guidance 05/04/11
Current Good Manufacturing Practices (cGMPs) Non-Penicillin Beta-Lactam Risk Assessment: A cGMP Framework Draft Guidance 03/04/11
Current Good Manufacturing Practices (cGMPs)/Compliance Process Validation General Principles and Practices Final Guidance 01/24/11
Current Good Manufacturing Practices (cGMPs)/Compliance The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practices (cGMP) Final Guidance 01/26/10
Current Good Manufacturing Practices (cGMPs)/Compliance PET Drug Products- Current Good Manufacturing Practices (cGMP) Final Guidance 12/09/09
Current Good Manufacturing Practices (cGMPs)/Compliance Pharmaceuticals Components at Risk For Melamine Contamination Final Guidance 08/06/09
Current Good Manufacturing Practices (cGMPs)/Compliance Current Good Manufacturing Practice for Phase I Investigational Drug Final Guidance 07/14/08
Current Good Manufacturing Practices (cGMPs)/Compliance Computerized System Used in Clinical Trials Final Guidance 05/10/07
Current Good Manufacturing Practices (cGMPs)/Compliance Testing of Glycerin for Diethylene Glycol Final Guidance 05/01/07
Current Good Manufacturing Practices (cGMPs)/Compliance Prescription Drug Marketing Act (PDMA) Requirements Q&A Final Guidance 11/13/06
Current Good Manufacturing Practices (cGMPs)/Compliance Investigation Out-of-Specification Test Results for Pharmaceuticals Production Final Guidance 10/11/06
Current Good Manufacturing Practices (cGMPs)/Compliance Quality Systems Approach to Pharmaceuticals Current Good Manufacturing Practices Regulations Final Guidance 09/27/06
Current Good Manufacturing Practices (cGMPs)/Compliance Prescription Drug Marketing Act – Donation of Prescription Drug Samples to Free Clinics Final Guidance 03/01/06
Current Good Manufacturing Practices (cGMPs)/Compliance Formal Dispute Resolution : Scientific and Technical Issues Related to Pharmaceutical cGMP PRA  Final Guidance 01/11/06
Current Good Manufacturing Practices (cGMPs)/Compliance Expiration Dating of Unit-Dose Repackaged Drug: Compliance Policy Guide  Draft Guidance 05/31/05
Current Good Manufacturing Practices (cGMPs)/Compliance Current Good Manufacturing Practice For Combination Products  Draft Guidance 10/04/04
Current Good Manufacturing Practices (cGMPs)/Compliance PAT-A Framework for Innovative, Development, Manufacturing and Quality Assurance  Final Guidance 09/29/04
Current Good Manufacturing Practices (cGMPs)/Compliance Sterile Drug Product Produced by Aseptic Processing – Current Good Manufacturing Practice  Final Guidance 09/29/04
Current Good Manufacturing Practices (cGMPs)/Compliance Powder Blends and Finished Dosages Units – Stratified In-Process Dosage Unit Sampling and Assessment (Revised)  Draft Guidance 11/01/03
Current Good Manufacturing Practices (cGMPs)/CMC Comparability Protocols – Protein Drug Products and Biological Products – Chemistry Manufacturing and Control Information  Draft Guidance 09/05/03
Current Good Manufacturing Practices (cGMPs)/ Compliance Part- 11 , Electronic Records ; Electronic Signatures – Scope and Application  Final Guidance 09/03/03
Current Good Manufacturing Practices (cGMPs)/ Compliance Current Good Manufacturing Practices For Medical Gases  Draft Guidance 05/06/03
Current Good Manufacturing Practices (cGMPs)/ Compliance Pharmacy Compounding- Compliance Policy Guide  Final Guidance 05/01/02
Current Good Manufacturing Practices (cGMPs)/ Compliance Guidance for Hospitals, Nursing Homes and Other Health Care Facilities – FDA Public Health Advisory  Final Guidance 04/05/01
Current Good Manufacturing Practices (cGMPs)/ Compliance Manufacturing, Processing or Holding Active Pharmaceuticals Ingredients  Draft Guidance 04/17/98
Current Good Manufacturing Practices (cGMPs)/ Compliance Good Laboratory Practice Q&A  Final Guidance 03/02/98
Current Good Manufacturing Practices (cGMPs)/ Compliance Expiration, Dating and Stability Testing of Solid Oral Dosages Form Drugs Containing Iron  Final Guidance 06/27/97

 

 

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