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The FDA is soon to explore new “intermediate” approval pathways that might be more appropriate for certain cellular and gene therapy products than the regulatory pathways they face now. Read More
A planned International Council for Harmonization (ICH) guideline on model-informed drug development (MIDD) will help optimize clinical trial designs, according to ICH, which estimates development of the guideline will be complete in three to four years. Read More
The European Medicines Agency’s (EMA) safety committee has warned that Jazz Pharmaceuticals’ Defitelio (defibrotide) should not be used for preventing veno-occlusive disease (VOD) — a rare condition in which veins in the liver become clogged and stop the liver from functioning properly. Read More
The FDA’s Center for Biologics and Evaluation Research (CBER) put out its planned list of guidance documents it expects to release in 2022, including several that focus on gene therapies and regenerative medicines. Read More
A new draft guidance from the FDA describes the benefit-risk principles the agency would apply when evaluating product quality for New Drug Applications (NDAs), Biologics License Applications (BLAs) or supplements to such applications. Read More
In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance. Read More