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A generic drug-dispensing program created by San Diego-based Medvantx is making it easier for doctors to prescribe more generic drugs for patients with a machine that dispenses samples on the spot.
Life sciences industry spending on IT is rising rapidly and poised to accelerate more than 15 percent each year through 2011, in part due to Part 11 compliance and legacy system remediation projects, says a new survey from Frost & Sullivan.
A well-crafted risk assessment and management program can strengthen a firm’s compliance efforts by providing clarity, easing the regulatory workload and generally making the operation run more smoothly, experts said last week at an industry conference.
The FDA has not lost interest in electronic data integrity, audit trails or computer system validation, even though it has stated it will exercise enforcement discretion regarding 21 CFR Part 11, experts stressed at FDAnews’ recent FDA Information Management Summit in Bethesda, Md.
Drugmakers that fail to lay good groundwork now for their structured product labeling (SPL) programs could leave “a lot of future benefits on the table,” according to an industry expert.
Sponsors considering submitting clinical study data to the FDA based on Study Data Tabulation Model (SDTM) standards should provide early samples of data to familiarize agency reviewers with the new electronic format, experts say.
Sponsors considering submitting clinical study data to the FDA based on Study Data Tabulation Model (SDTM) standards should provide early samples of data to familiarize agency reviewers with the new electronic format, experts say.
Drugmakers that fail to lay good groundwork now for their structured product labeling (SPL) programs could leave "a lot of future benefits on the table," according to an industry expert.
The FDA will continue to increase its emphasis on esubmissions next year, former agency chief information officer (CIO) James Rinaldi told attendees of the FDA Information Management Summit sponsored by FDAnews in Bethesda, Md., Dec. 1. Rinaldi left the agency in August to become CIO of NASA’s Jet Propulsion Laboratory.