Content of Premarket Submissions for Device Software Functions

Content of Premarket Submissions for Device Software Functions guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s…

Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk

Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk. M7(R2) Assessment and Control…

CDER Program for the Recognition of Voluntary Consensus Standards

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality guidance describes a program at FDA’s Center for Drug Evaluation and…

Guidance on pediatric submission

The updated guidance of Pediatric submission of product. These guidelines suggest what things are necessary and what is not required.

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities

Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products