Recently Posted Guidance Documents

Recently Posted Guidance Documents

9/3/2020 - Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling 9/2/2020 - Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry 9/2/2020 - Investigational COVID-19 Convalescent Plasma: Guidance for Industry 8/31/2020 - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders