At FOIA Document Source, we specialize in helping you navigate the complex process of requesting information from the FDA and other global regulatory agencies. Below is an overview of the types of documents and information you can request, categorized by different areas of interest. This is not an exhaustive list, but serves as an example of what you can request.
NOTE: To learn about the different agencies we submit requests to, read "Top Government Agencies for FOIA Requests"
Key FDA Document Types
- NDA Approval Letters: These letters outline the basis for the approval of New Drug Applications, providing insights into the approval process for new drugs.
- Drug Review Pages: Detailed reviews of drugs, including evaluations of efficacy and safety.
- Summary Basis of Approval: Comprehensive summaries detailing the reasons for drug approval decisions.
- ANDA Approval Letters: Approval letters for Abbreviated New Drug Applications, typically for generic drugs.
- Dissolution Reviews: Documents exploring dissolution testing results and methodologies for specific drugs.
- 510(k) Documentation: Submissions for medical devices demonstrating substantial equivalence to legally marketed devices.
- SS&E Documentation: Safety and Effectiveness documentation for medical devices.
- Establishment Inspection Reports (EIRs): Detailed reports of FDA inspections at various establishments.
- Form 483: Documents outlining observations made during FDA inspections.
- Company/FDA Correspondence: Correspondence between companies and the FDA regarding inspections and compliance.
- Color Additive Petitions: Petitions for the approval of color additives in food products.
- Food Additive Petitions: Petitions for the approval of various food additives, including safety assessments.
- Biologic Summary Basis of Approval: Summaries for the approval of biological products.
- Biologic 510(k): Submissions for biologic devices showing substantial equivalence to existing products.
- Veterinary FOI Summaries: Summaries of FOIA documents related to veterinary drugs
By requesting these documents, you can gain valuable insights into the FDA's regulatory processes, approval decisions, and compliance requirements. Our team at FOIA Document Source is here to assist you in formulating precise and effective FOIA requests to obtain the information you need.