FDA Issues Six Draft Guidance Documents
On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.
On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States. This guidance enforces the ICH Q3C Guideline for Residual Solvents.
On August 4, 2008, the FDA also issued five ICH draft guidelines for review and consultation under Step 3 of the ICH process.
The five ICH guidelines that were released are:
- Guidance for Industry: International Conference on Harmonization; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions;
- Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
- Annex 5: Disintegration Test General Chapter
- Guidance for Industry: Labeling OTC Skin Protectant Drug Products
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
