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New GMP Guidelines by FDA for 2019 Response by CDER

Updated: 27 March 2019

Five pages and 15 individual categories were presented by Center for Drug Evaluation and Research to share the plan for guideline revision including Biosimilars to rare diseases. Revised guidelines related with GMP can be found under “Pharmaceutical Quality/Microbiology” and the "CMC" part of the approval.

Some of the guidelines include Microbiological Considerations for Non-Sterile Drug Products, Comparative Analytical Assessment to Support a Demonstration of Biosimilarity to a Therapeutic Protein Product, ANDAs: Stability Testing of Drug Substances and Products Questions and Answers.

It also includes Inspection of Injectable Products for Visible Particulates, Setting Endotoxin Limits during Development of Investigational Oncology Drugs and Biologics, Harmonizing Compendial Standards with Drug Application CMC Approval requirements Using the USP Pending Monograph Process, Bridging for Drug-Device and Biologic-Device Combination Products and Qualification Process for Drug Development Tools.