2020 CDER Draft and Revised Guidance: What’s Coming

Regulatory NewsRegulatory News | 30 January 2020 |  By 

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In the pharmaceutical quality/CMC category, CDER is expecting to publish a new draft guidance titled,“Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” in addition to one on ICH Q12 and one building off FDA’s work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.”

In related draft guidance in the procedural category, CDER is planning one on “IND submissions for Individualized Antisense Oligonucleotide Therapies: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators,” as well as new draft guidance on the tropical disease priority review voucher program.

In the new biostatistics category, CDER is planning three new draft guidances on: “Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biologics Using Nonlinear Models,” “Multiple Endpoints in Clinical Trials and Statistical Aspects of the Design,” and “Analysis and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals.”

New drafts in the clinical/medical category that were not on 2019’s list include guidance on decentralized clinical trials, use of data monitoring committees in controlled clinical trials, and the use of digital health technologies for remote data acquisition in clinical investigations.

CDER also plans to release a new draft this year on regulatory considerations for diagnostic devices that reference therapeutic products.

Meanwhile, quite a few of the draft guidance documents on the 2020 list are repeats from 2019, including two on ANDA submissions (refuse-to-receive for DMF facilities deficiencies and refuse-to-receive standards: questions and answers), one on three-year exclusivity determinations for drugs, one on cross labeling oncology drugs in combination drugs, one on assessing the effects of food on drugs in INDs or NDAs, as well as those titled, “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics,” “Notifying FDA of Permanent Discontinuance or Interruption in Manufacturing or Drug or Biological Product,” and “Risk Management Plans to Mitigate the Potential for Drug Shortages,” among others.

And CDER’s planned draft guidance titled, “Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements,” has been lingering on the list since 2017.

2020 List of CDER Guidance


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