You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
Topics: Medical Devices, Draft Guidance, FDA
On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the public on “emerging signals” regarding medical devices that are already used in clinical practice. The FDA defined an emerging signal as “new information about a medical device” that:
Topics: Draft Guidance, FDA, Emerging Signals
This is the second of a two blog series on the Draft Guidance for Institutions and IRBs. The first blog was published on January 7, 2016.
In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.
Topics: Draft Guidance, IRBs, FDA, Institutions
The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.
Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings
The FDA evaluates the disclosure of financial information from clinical investigators to determine the reliability of data submitted to the FDA and identify steps to minimize the potential for bias. The value of an investigator’s financial interest in the sponsor may have the potential to increase if the product is approved. 21 CFR 54 states that investigators must disclose significant equity interest in the sponsor, any proprietary interest in the sponsor and significant payments of other sorts from the sponsor during the time the investigator is carrying out the study and for a period of one year following completion of the study.
Topics: Draft Guidance, Financial Disclosure, FDA
Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice. The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland). This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996.
Topics: Good Clinical Practice, ICH GCP, Draft Guidance, FDA
On April 1st, the FDA issued a draft guidance that provides more comprehensive information for industry and CDRH on the processes associated with panel device meetings. The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels overseen by FDA's Center for Devices and Radiological Health (CDRH), the FDA center in charge of regulating medical devices.
Once finalized, the updated guidelines will replace a 2000 CDRH guidance document on the panel process and a 1991 blue book memo. Thus, the guideline clarifies the circumstances in which the CDRH consults with a device advisory panel, the conduct of panel meetings and the expected timelines to prepare for a panel meeting.
Topics: Medical Devices, Draft Guidance, FDA, CDRH
The FDA issued its final guidance on electronic source documentation. Back in January 2012 the FDA published its draft guidance to much criticism and debate. The new guidance broadly follows the second draft of the guidance which was released in November 2012.
Topics: FDA Guidance, Draft Guidance, Electronic Source Documentation
According to a news-release on Federal Register, FDA has finalized the draft guidance released in December 2011 under the same title “Humanitarian Use Device (HUD) Designations”. The guidance FDA published is intended to provide further information and assistance to those preparing applications/submissions as well as FDA reviewers when dealing with this special class of devices.
Topics: Draft Guidance, Humanitarian Use, Device Designations, FDA
What exactly is a Home Use Device? FDA’s website defines this as “a medical device intended for users in any environment outside of professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes. Typically the following standards are met:
Topics: Draft Guidance, Home Use of Medical Devices, FDA
In August 2011, FDA released a draft guidance document recommending a Risk-Based approach to monitoring. Risk- Based Monitoring combines the vigilance and data surveillance (key features of Electronic Data Capture systems) with traditional on-site data verification targeting critical data points. Rather than a standardized monitoring plan, Risk-Based Monitoring aims to adapt the monitoring plan to the changing needs of the Study, Site and Investigational Product.
Topics: Sandra Maddock, Risk-Based Monitoring, Draft Guidance, FDA