Recently Posted Guidance Documents on Drugs, Biologics, Devices, and Veterinary

Devices

7/27/2018  Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

Biologics

7/26/2018 Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry

Drugs

7/26/2018  Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry

7/24/2018  Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

7/23/2018  Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry

Veterinary

7/24/2018 CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species