11 August 2020
What are the FDA's plans for 2018? The Center for Drug Evaluation and Research (CDER) has answered that question in their list of guidelines which they plan to publish or to revise. These documents are presented on almost five pages, divided into individual categories. Some of these categories include specific subjects, such as advertising, rare diseases and user fees.
In the subject of GMP there are guidelines, which are planned to be published or to be revised. They are divided in various categories. In the category Pharmaceutical Quality/Microbiology, there is a reference to a guideline on microbiological considerations for non-sterile drugs. The category Pharmaceutical Quality/CMC includes a reference to a revised draft on Drug Master Files, a guideline on the harmonisation of pharmacopoeial methods for post-approval changes to APIs. A guideline on quality requirements for continuous manufacturing is also planned.
In the actual cGMP category Pharmaceutical Quality/Manufacturing Standards, only two guidelines are mentioned. There is one on the subject of Compounding and one about Field Alert Report Submissions.
On the FDA website you can find the complete Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018.