This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|July 2, 2003
- Pharmaceutical Technology-07-02-2003
- Volume 27
- Issue 7
Understanding and Implementing a Risk-Based Approach to 21 CFR Part 11 Compliance
Pharmaceutical companies must take a holistic look at their systems and supporting processes to implement FDA's risk-based approach into their 21 CFR Part 11 complaince strategies.
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Articles in this issue
about 23 years ago
July 2003about 23 years ago
The Push for Generics Challenges Manufacturersabout 23 years ago
Emerging Research Opportunities in Oral Inhalation Technologyabout 23 years ago
Preventing Metal Contaminationabout 23 years ago
Capacity Worries Fade for BiomanufacturingAdvertisement
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The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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