Guidance Documents - Request for Comment

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing-and?utm_campaign=FDA%20Stakeholder%20Update%20-%20September%204%2C%202020&utm_medium=email&utm_source=Eloqua

Guidance Documents - Request for Comment

September 3, 2020 - Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling This guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out. September 2, 2020 - Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. September 2, 2020 - Investigational COVID-19 Convalescent Plasma: Guidance for Industry For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.

For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.