The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
|Articles|August 12, 2008
FDA Issues Six Draft Guidance Documents
Author(s)BioPharm International Editors
On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.
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On August 6, the FDA released a guidance entitled
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- Guidance for Industry: International Conference on Harmonization; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions;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
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