Chemical Entity Products/Quality
- Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) [2024-12-18]
- Guidance Document: Addendum - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers [2017-10-30]
- Guidance Document: Certified Product Information Document - Chemical Entities (CPID-CE) [2017-10-30]
- Glossary of Quality Terms [2017-10-30]
- Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions [2017-08-21]
- Policies
- Quality Overall Summary - Chemical Entities (QOS-CE) Templates
- Good Manufacturing Practices
- Guidance Document Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals [2008-04-21]
- Guidance for Industry: Pharmaceutical Quality of Inhalation and Nasal Products [2006-02-01]
- Guidance for Industry: Pharmaceutical Quality of Aqueous Solutions [2005-02-15]
- Draft Guidance for Industry: Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals [2003-07-16]
- Stereochemical Issues in Chiral Drug Development [2000-02-14]
- Reduction in the use of Dichloromethane in Tablet Coating Operations [1997-07-21]