The U.S. Food and Drug Administration issued a guidance on voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities.
Draft FDA Guidance for Computer Software Assurance for Production and Quality System Software
The FDA issued a draft Guidance for Computer Software Assurance for Production and Quality System Software.
Read MoreFDA Responses to Good Clinical Practice Inquiries
FDA answers GCP questions
Read MoreConduct of Clinical Trials During the COVID-19 Public Health Emergency
The U.S. Food and Drug Administration has issued a guidance document to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with Good Clinical Practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.
The appendix to the guidance provides recommendations for deciding whether to suspend, continue or initiate clinical trials, managing protocol deviations and amendments, conducting remote (virtual) clinic and monitoring visits, and obtaining informed consent for patients in isolation.
The full guidance may be downloaded here
FDA Issues Guidance on Remote Inspections
FDA Remote Inspections
Read MoreFDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials
The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. The agency is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics.
FDA MyStudies is now referred to as COVID MyStudies in the Apple App and Google Play stores. The display name that appears underneath its icon after it has been downloaded is COVID19.
Through the COVID MyStudies app, the investigator can send the informed consent document electronically to the patient or his or her legally authorized representative. Once the patient or representative has signed the form, he or she will receive an electronic copy. The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically.
Obtaining informed consent remotely can help make sure clinical trials are not unnecessarily delayed during the COVID-19 public health emergency. Methods for obtaining informed consent remotely were discussed in a recent FDA guidance, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The guidance encouraged investigators to consider using electronic methods of obtaining informed consent if possible.
Harvard Pilgrim Health Care Institute, which operates the Sentinel and Catalyst systems on behalf of the agency, will provide the technical assistance required for the COVID MyStudies app. To facilitate free use of the app during the public health emergency, FDA intends to fund this assistance as resources permit. Before using the COVID MyStudies app, investigators will provide their informed consent documents to the COVID MyStudies team to be added to the app. They will then have a chance to review all informed consent documentation within the app before incorporating it into their trials. There is also an opportunity for investigators to incorporate clinical trial-specific branding within the app. Regardless of whether they use the COVID MyStudies app, investigators must comply with applicable requirements for IRB review and approval of the informed consent document and process.
Investigators interested in using the COVID MyStudies app should contact the CDER Real-World Evidence Program at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov and reference their pre-IND or IND numbers if applicable. FDA plans to prioritize requests to use the app, taking into account agency resources.
FDA Guidance on Conduct of Clinical Trials during COVID-19
FDA guidance on the conduct of clinical trials of medical products during the coronavirus (COVID-19) Public Health Emergency
Read MoreFDA Guidance on Providing Regulatory Submissions in Electronic and Non-Electronic Format
The U.S. Food & Drug Administration (FDA) issued a guidance on providing regulatory submissions in electronic and non-electronic format. This guidance pertains to submissions of promotional materials for human prescription drugs to the FDA made by manufacturers, packers, and distributors, whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This guidance also explains certain aspects of electronic submission of promotional materials in module 1 of the electronic common technical document (eCTD).
FDA issues guidance for Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
FDA announced the availability of a new guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” This guidance clarifies that certain provisions of the 2018 Requirements related to informed consent are not inconsistent with FDA’s current policies and guidances. The guidance also reminds stakeholders that FDA’s current regulations for expedited review and continuing review must be followed for FDA-regulated studies.
The revisions to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule” or “2018 Requirements”) have created certain differences between FDA’s human subject regulations and HHS’ human subject regulations. While FDA intends to undertake rulemaking to harmonize, to the extent practicable and consistent with other statutory provisions, its regulations with the 2018 Requirements consistent with Section 3023 of the 21st Century Cures Act, we recognize the potential for confusion in the interim for sponsors, investigators, and IRBs who are involved in both HHS-regulated research and FDA-regulated clinical investigations. This guidance is intended to clarify the impact of certain provisions of the 2018 Requirements on FDA-regulated clinical investigations.
The guidance is available to download on FDA’s website
Final FDA Guidance on Bioanalytical Method Validation
FDA Final Guidance on Bioanalytical Method Validation
Read MoreFDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices
Today the FDA issued both the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” and the guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.
The final rule amends FDA regulations on acceptance of data from clinical investigations conducted outside the United States to reflect the increasing globalization of clinical trials and the evolution of clinical trial standards for protecting human subjects. The new rule requires that sponsors and applicants provide statements and information about how the investigations conform with good clinical practices (GCP). This applies to clinical data submitted to support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), and humanitarian device exemptions (HDE). The FDA believes that the requirements set out in the final rule provide flexibility for medical device sponsors conducting multinational clinical trials by allowing them to describe the standard for good clinical practice they followed.
The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the United States to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs. This change is intended to provide consistency across different submission or application types.
The guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions ” is in question and answer format and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations.
FDA Guidance for IRB Waiver or Alteration of Informed Consent
The United States Food and Drug Administration (FDA) issued a guidance for immediate implementation to Sponsors, Investigators, and Institutional Review Boards for the waiver of alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects.
Read MoreDraft FDA Guidance on Electronic Records and Electronic Signatures in Clinical Investigations
FDA announced the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers.” The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under 21 CFR part 11 in clinical investigations of medical products.