FDA Takes Action on Unreported Study Results; First Notice of Noncompliance

5/18/2021

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The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.

FDA Issues Final Rule: Software as Medical Device Classification Regulation Update Aligns with Cures Act

5/11/2021

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The US Food and Drug Administration (FDA) issued a final rule that changes the classification of some software so that it no longer is regulated as a medical device. The rule was needed to align with updates required by the 21st Century Cures Act (Cures Act). The Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to remove certain software from being classified as a medical device, including software used:

Insufficient Dosing to Vulnerable Population Within a Clinical Trial Leads to FDA Warning Letter

5/05/2021

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New Warning Letter Issued

A warning letter was issued to Dr. Evelyn Lopez-Brignomi, M.D. this March in regards to “objectionable conditions observed during an FDA inspection conducted at her clinical site between June 8 and June 23, 2020.” This study contained pediatric subjects who are a vulnerable population which raises concern about the severity of the violation and their potential impact on subjects’ rights, safety, and welfare.

Overinterpretation of Safety Reporting Regulations Leads to Burdens at Sites, FDA

4/27/2021

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There has been an increase in the complexity of clinical trials over the last decade. Add to that the support for including more diverse populations who may have additional underlying conditions (FDA Guidance document “Enhancing the Diversity of Clinical Trial Populations”), and this leads to an increase in the number of safety events reported.

Now Available for Purchase: Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures eLearning

4/20/2021

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Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures interactive eLearning is now available for purchase in our online store HERE.

This interactive eLearning can be used alone or as part of the full curriculum (see more below).

The course provides an overview of the key concepts and best practices for following the U.S. Food and Drug Administration’s (FDA) applicable regulations for financial disclosure, electronic records, and electronic signatures. These topics are applicable to drug, device, and biologic studies. Required by 21 CFR Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. 21 CFR Part 11describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.