Recently Posted Guidance Documents

• 7/11/2019 - Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry
• 7/11/2019 - Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff
• 7/11/2019 - Population Pharmacokinetics
• 7/10/2019 - Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry 
• 7/10/2019 - Using the Inactive Ingredient Database Guidance for Industry
• 7/9/2019 - Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry