Blog RSS 04/23/2024 Photo by CharlesDeluvio on Unsplash On March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings. The first five observations were all violations of 21 CFR 56.108(b) and 56.115(a)(6), the requirement for IRBs to prepare, maintain, and follow required written procedures for ensuring prompt reporting to the I ..read more

Blog RSS 04/09/2024 Photo by Arisa Chattasa on Unsplash Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience ..read more

Blog RSS 04/02/2024 Photo By Jason Goodman on Unsplash The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006.  The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials. The majority of the facts and definitions surrounding DMCs have stayed the same from the 2006 guide to 2024 ..read more

Blog RSS 01/03/2024 Photo by: Canva On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans. The FDA Warning Letter highlighted the following protocol violations: Subjects were concurrently or consecutively enrolled in studies whi ..read more

Blog RSS 11/07/2023 On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued an investigator Warning Letter to Angela M. Stupi, M.D.. There were multiple deficiencies noted at Dr. Stupi’s clinical site. The site enrolled participants who were ineligible per protocol and did not follow the requirements for administering the investigation product.  Here are the specifics highlighted: 1. Failure to Ensure Eligibility Criteria Were Met Participants were enrolled who did not meet the enrollment criteria per protocol. This failure raised concerns about the integrity of the data an ..read more

Blog RSS 10/24/2023 Photo by: Canva On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017. The draft guidance elaborates on the principles of effective meeting management practices and presents standardized procedures for facilitating formal meetings. While ..read more

Blog RSS 09/27/2023 Photo by: Canva On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation. The confirmatory evidence guidance expands on the draft guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (20 ..read more

Blog RSS 09/13/2023 Photo by Ross Findon on Unsplash Guest blogger McKenna Fuller On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative. The three new draft guidances are: Best Practices for Selecting a Predicate: FDA-2023-D-3134 Clinical Data in 510 ..read more

Blog RSS 8/29/2023 Photo by Jair Lázaro on Unsplash The US Food and Drug Administration (FDA) offers a voluntary program that qualifies tools that sponsors may use in support of the development and evaluation of medical devices known as the Medical Device Development Tools (MDDT) program. Some examples of tools that may be included are electronic patient reported outcomes (ePRO) or wearables. Once tools are qualified by the FDA, the sponsor does not need to requalify if using the tool for the same purpose. The FDA evaluates tools submitted to the MDDT program if they are fit fo ..read more

Blog RSS 08/08/2023 Photo by John Adams on Unsplash The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions pageequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements. The Program was an FDA commitment under PDUFA VII, approved as part of the FDA User Fee Reauthorization Act of 2022. RWE provides valuable inform ..read more