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India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Research heads of 19 global pharmaceutical companies signed on to an open letter calling for a quick decision to relocate the European Medicines Agency from London, post-Brexit — preferably at the June meeting of the European Council. Read More
Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More
The FDA published draft revisions to its blueprint for educating health care providers about extended-release and long-acting opioid painkillers. Read More