CDER lays out 2021 guidance agenda
The FDA’s Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021.
The agenda, while oftentimes aspirational, provides insights as to what the agency’s drug center’s new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021.
Many of the planned guidances on the list were included in previous years’ agendas, such as the proposed clinical pharmacology draft guidance “Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations,” and updated guidance on “Pharmacogenomic Data Submission” and “Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling.”
In total, there are 105 guidances included on the agenda, 42 of which are new for 2021. The new guidances not carried over from 2020 are presented in the table at the bottom of the article. This year there are four new categories of draft guidances that appear on the agenda that were not included in 2020: animal rule, biosimilars, compounding and pharmacology/toxicology.
Some of the notable new guidances include a guidance on meeting the standard for substantial evidence based on a single adequate and well-controlled clinical trial plus confirmatory evidence and a guidance aimed at class-specific recommendations for biosimilars and interchangeable products. Several of the guidances on the agenda are aimed at providing recommendations for individualized antisense oligonucleotides (ASO), including guidance on clinical recommendations to support investigational new drug application (IND) submissions, nonclinical testing, and on chemistry, manufacturing and controls (CMC) considerations for the so-called “n of 1” therapies.
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