What are FDA's Plans Concerning New (GMP) Guidelines for 2019? The CDER give answers

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20/21 December 2022

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What are FDA's plans concerning new guidelines for calendar year 2019? The Center for Drug Evaluation and Research (CDER) has provided an answer to that question in its list of planned guidelines and/or guidelines to be revised. These documents are presented over five pages, divided into 15 individual categories. These categories partly cover very specific topics, from biosimilars to rare diseases.

Regarding GMP, planned and/or revised guidelines can be found under various sections, e.g. under the categories "Pharmaceutical Quality/Microbiology" and the "CMC" part of the approval. Below, you will find some of the planned/to be revised guidelines with a direct or indirect connection to GMP:

• Comparative Analytical Assessment to Support a Demonstration of Biosimilarity to a Therapeutic Protein Product
• Bridging for Drug-Device and Biologic-Device Combination Products
• Microbiological Considerations for Non-Sterile Drug Products
• Harmonizing Compendial Standards with Drug Application CMC Approval requirements Using the USP Pending Monograph Process
• Transdermal and Topical Delivery Systems- Product Development and Quality Considerations
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
• Stability Considerations for NDAs, ANDAs and BLAs
• ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
• Qualification Process for Drug Development Tools 
• Inspection of Injectable Products for Visible Particulates
• Quality Considerations for Continuous Manufacturing (CM) - already published  

  
You can find the complete document entitled "Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019" on FDA's website.