European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.   ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement . EMA released the standard along with the European Commis...

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).   In the draft guidance , FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).    The guidance implements section 745(A)(...

The US Food and Drug Administration on Thursday issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.   The guidance contains few changes from the draft issued in March 2020. (RELATED: FDA Drafts Guidance on Alternate Electronic Formats, Announces Support for New Data Standards , Regulatory Focus, 10 March 2020 ). In its fina...

Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...

Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...

In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.   The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public C...

Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics . The ingestible sensors used in the trial can sense oxygen, hydrogen and carbon dioxide by using a combination of thermal conductivity and semiconducting sensors, the researchers said,...

Following its manufacture and distribution of adulterated automatic external defibrillators (AEDs) and Q-CPR meters, which the U.S. Food and Drug Administration (FDA) said put people at risk, US District Judge Denise Casper on Tuesday entered a consent decree of permanent injunction between the US and Andover, MA-based Philips North America LLC and two company officers. Under a complaint filed on behalf of FDA and alongside the consent decree, Philips was said to be...

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms. Unlike superiority trials, which test whether a new drug has greater efficacy than an existing therapy, noninferiority studies test that the new treatment does not fall outside a predetermined range of "clinically acceptable" inferi...

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants. While the guidance was released without a public consultation on a draft version, FDA says it will consider comments on the final version and revise the guidance as necessary. "Over the years, FDA has received numerous...

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...

The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...