FDA announces intended guidance topics for 2015

The FDA has published a list of new and draft guidance documents that it plans to publish during 2015.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.