FDA announces new initiatives for inspections and clinical trials

By PharmaCompass

2018-11-15

Impressions: 120 Article

The US Food and Drug Administration (FDA) is modernizing its inspections program with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs. With this measure, the agency hopes to avert drug shortages and question marks over sterility of drug products.

“This New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings. The protocols also include additional questions related to quality culture observed in facilities,” FDA Commissioner Scott Gottlieb said.

The FDA conducted multiple pilots of the NIPP protocols to ensure they would be consistent with the current program objectives and can be integrated into the way investigators conduct inspections.

Meanwhile, the FDA has also released an open source code app — MyStudies — that can be used to collect real-world data directly from patients, including from their mobile devices.

The MyStudies app is a digital platform that can be used to collect data from a “variety of sources, such as electronic health records, claims and billing activities, product and disease registries, as well as patient-generated data including in home-use settings, as well as data gathered from other sources, such as mobile devices,” an FDA announcement said. The app can be customized and used to administer questionnaires assessing patient-reported outcomes, symptom scales or patient reports of medication use.

“There are a lot of new ways that we can use real world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable. Better capture of real world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development,” Gottlieb said.

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