USA – 2020 CDER Draft and Revised Guidance: What’s Coming

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Thursday unveiled its list for 2020 guidance documents, with the bulk of the new and revised drafts falling into categories related to generic drugs, pharmaceutical quality/CMC and procedural work.

Unlike the list from 2019, this year’s list includes new categories of guidance on biostatistics, clinical/antimicrobial, marketing/advertising (one new one on labeling and advertising for biologics and biosimilars) and over-the-counter drugs. However, 2019’s list also included categories that are not in the 2020 list, including those on rare diseases, combination products, clinical/statistical and drug development tool draft guidances.

In the pharmaceutical quality/CMC category, CDER is expecting to publish a new draft guidance titled,“Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” in addition to one on ICH Q12 and one building off FDA’s work on n-of-1 trials, on “Chemistry Manufacturing and Controls Considerations for Individualize Antisense Oligonucleotide (ASO) Therapies.”…