# INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/inds-for-phase-2-and-phase-3-studies-chemistry-manufacturing-and-controls-information-guidance-for-industry/f47444ad-ffd7-42ea-816d-1d6da8a15bf1

> FDA guidance document: INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information:  Guidance for Industry. Issue date: May 20, 2003. Get complete insights and analysis.

---

## Details

- Title: INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2003-05-20
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0030">FDA-1999-D-0030</a>

## Related Documents

- [ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/andaspharmaceutical-solid-polymorphism-chemistry-manufacturing-and-controls-information-guidance-for-industry/ea6f758d-a4f3-4afe-b529-2949f9e35169)
- [Nonclinical Safety Evaluation of Pediatric Drug Products](https://www.globalkeysolutions.net/guidances/guidance-document/nonclinical-safety-evaluation-of-pediatric-drug-products/a5729b5c-7a6e-40c1-861d-e8acf3cd178a)
- [Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy](https://www.globalkeysolutions.net/guidances/guidance-document/drug-products-containing-ensulizole-hypromellose-meradimate-octinoxate-and-octisalate-labeling-enforcement-policy/4320b2a8-6f77-4cbf-8a20-7b9631fcf4fe)