FDA Issues Six Draft Guidance Documents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- Guidance for Industry: International Conference on Harmonization; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions;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
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
