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Latest From Sue Sutter
Expanded access program for rare pediatric disease treatment did not enroll many patients due to clinician community overwhelmed by patient demand and questions over who would pay ancillary drug costs.
Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.
Information about an investigational drug and companion in vitro diagnostics may be submitted in a single investigational new drug application to the agency's drug or biologics centers, eliminating the need for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft guidance.
Information about investigational drug and in vitro diagnostic may be submitted in single IND to agency's drugs or biologics centers, eliminating need for separate submission to devices center; new process should give greater therapeutic context to decisions of whether the IVD is considered a significant risk.
Sponsors generally should begin pediatric studies after obtaining initial evidence of efficacy and safety from early phase adult trials rather than waiting until initial approval in adults, agency says in a new draft guidance; move toward earlier timeline for pediatric research aligns with recommendations from a 2015 advisory committee, and patient and professional groups.
Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.