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Before wasting time and money on a clinical trial, sponsors should determine whether additional preclinical studies are needed to rule out a drug candidate’s potential for endocrine-related adverse effects, the FDA says. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
The European Commission has approved Novartis’ Farydak as the first histone deacetylase inhibitor for treatment of multiple myeloma available in the EU. Read More
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner Coumadin and its generic version, warfarin. Read More
HHS Wednesday proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More