Recently Posted Guidance Documents

Drugs

8/8/2018  Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry

8/7/2018  Elemental Impurities in Drug Products Guidance for Industry

8/6/2018  Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry