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The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More
Human radiolabeled mass balance studies are the most direct way of gathering quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft guidance the FDA issued last week. Read More
On Monday, a two-week trial got under way to determine the contributions that pharmacy chains CVS Health Corp, Walgreens Boots Alliance and Walmart made to the opioid crisis in two hard-hit Ohio counties. Read More
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A new draft guidance from the FDA describes the benefit-risk principles the agency would apply when evaluating product quality for New Drug Applications (NDAs), Biologics License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