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Latest From Sue Sutter
FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.
At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.
Web portal makes it easier for non-industry stakeholders to request meetings on development and safety matters but might sow confusion for some patient groups, particularly when it comes to externally led patient-focused drug development meetings.
Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.
US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.
Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.