USA – CDER issues list of draft guidances for release this year

The US Food and Drug Administration’s (FDA) 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. (RELATED: 2020 CDER draft and revised guidance: What’s comingRegulatory Focus 30 January 2020).
 
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the planned guidances on the list were included in previous years’ agendas, such as the proposed clinical pharmacology draft guidance “Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations”, and updated guidance on “Pharmacogenomic Data Submission” and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”…