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The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Read More
An FDA advisory committee voted unanimously in favor of combining patients with bladder pain syndrome and interstitial cystitis in clinical trials citing the minimal differences in symptoms between the two populations. Read More
The FDA is planning to deliver a suite of disease-specific guidance documents next year on developing targeted gene therapies, starting with hemophilia and then more common single-gene disorders, Commissioner Scott Gottlieb told senators Thursday. Read More