FDAsafety guidance54% confidence
Report on the State of Pharmaceutical Quality
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Aurobindo Pharma.
Regulatory Analysis
The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.
Supporting Context
- Therapeutic area
- Neurology · Pain Management
- Sub-indication
- Pain
Related signal: Aurobindo Pharma submits supplemental ANDA for Pregabalin