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|March 2, 2016
- Pharmaceutical Technology-03-02-2016
- Volume 40
- Issue 3
FDA GDUFA Testimony Presentation Slides
Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.
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Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.
Articles in this issue
over 10 years ago
Gaining Insight from Process Control Dataover 10 years ago
Phase-Appropriate GMPover 10 years ago
How Important is Data Integrity to Regulatory Bodies?over 10 years ago
Keynote Series Addresses Crucial Industry Issuesover 10 years ago
Polymorph Screening for Identification of Relevant Crystalline Formsover 10 years ago
Building Consensus for E&L Testing Standardsover 10 years ago
Multimode Microplate Reader Improves Sensitivityover 10 years ago
High-Pressure Ion Chromatography SystemAdvertisement
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PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
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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