« Previous
Next »
Titles
- Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- Fraud fighters1
- Implantable devices: regulatory framework and reform options1
- Long term follow-up after administration of human gene therapy products1
- Medical devices1
- Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff1
- Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic1
- Providing submissions in electronic format: postmarketing safety reports1
- The practicing physician and clinical research1
- Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff1