What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.
On the subject of GMP, guidelines that are planned and/or need to be revised can be found under various categories, most of them under "Pharmaceutical Quality" but also under "Procedures". The following is a selection of the planned / to be revised guidelines with direct or indirect reference to GMP:
PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
Chemistry Manufacturing and Controls Considerations for Individualize Antisense Oligonucleotide (ASO) Therapies
Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
ICH Q12, General Considerations for FDA Implementation
Inspection of Injectable Products for Visible Particulates
Quality Considerations for Topical Ophthalmic Drug Products
Quality and Stability Testing of Drug Substances and Drug Products for NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
Risk Management Plans to Mitigate the Potential for Drug Shortages
Benefit-Risk Considerations for Product Quality Assessments
Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers