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Tag: IND

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body: premarket approval applications (PMAs), humanitarian device exemption […]

FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

The FDA just issued draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports and associated technical specifications documents. The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research intends to implement a digital framework for the electronic submission, review, and tracking of certain investigational new drug (IND) safety […]

CDER SBIA Webinar Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)

Nov. 1, 2019 1:00 p.m. Eastern FREE FDA is establishing a new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide sponsors with a […]

VCU Faculty-Held IND and IDE Resources

Important policy, guidance, and resources are now available for research teams supporting VCU Faculty-Held Investigational New Drug applications (IND) or Investigational Device Exemptions (IDE). Essential resources found on the VCU Faculty-Held IND and IDE Resource Page include: VCU Policy:  Reporting Sponsor-Investigator INDs or IDEs VCU IND/IDE Procedure Handbook VCU Forms and Checklists Supporting IND/IDE Compliance VCU IND/IDE Submission […]

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