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the planned guidances on the list were included in previous years’ agendas, such as the proposed clinical pharmacology draft guidance “Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations,” and updated guidance on “Pharmacogenomic Data Submission” and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.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.