In the GMP relevant category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“ the following titles are listed:

• CDER’s Program for the Recognition of Voluntary Consensus Standards
• Drug Master Files; Revised Draft
• Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
• In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
• Transdermal and Topical Delivery Systems-Product Development and Quality Considerations
• Quality Considerations for Continuous Manufacturing (CM)
• Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software
• Using the Inactive Ingredient Database
• Risk Management Plans for Drug Manufacturers
• Quality Considerations for Topical Ophthalmic Drug Products
• Inspection of Injectable Products for Visible Particulates
• 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

The category of “Pharmaceutical Quality/Microbiology” lists – as in the previous year –

• Microbiological  Considerations  for  Non-Sterile   Drug  Products

This takes you directly to the "Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019".

Source:

FDA: What's new