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The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More
The co-conspirators also told doctors to have Medicare patients take medically unnecessary spinal facet joint injections to obtain prescriptions. Read More
China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More