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The Food and Drug Administration (FDA) has submitted a proposal to the Office of Management and Budget (OMB) for review, seeking to extend the collection of information related to drug, biological product, and device applications under the Paperwork Reduction Act. This involves certifications that accompany these submissions to ensure compliance with legal standards, including listing data for clinical trials in a registry. The FDA estimates that it will take approximately 15 to 45 minutes to complete the necessary certification forms, depending on the type of application, and aims to simplify compliance for sponsors and applicants. No public comments were received on this proposal when it was initially published.

The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.