The FDA has published a list of new and draft guidance documents that it plans to publish during 2015.
Several topics stand out among the 90 announced as potentially important for the clinical research industry:
- Standards for Clinical Trial Imaging Endpoints
- Dose Selection in Drug Development
- Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
- Multiple Endpoints in Clinical Trials (Statistical)
- Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
- Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
ClinDev will continue monitoring the FDA website for newly-released guidance.