FDA Warning Letter Regarding the Failure to Submit INDs for the Conduct of Clinical Investigations
with an Investigational Product that met the Definition of a Combined Product.
Inspections of clinical trials are conducted as a part of the U.S. Food and Drug Administration (FDA)’s Bioresearch Monitoring Program. These inspections are designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. Below you will find a short summary of a warning letter issued because of the failure to submit an investigational new drug application.
Warning Letter to Dr. David M. Lubeck/Arbor Centers for EyeCare
On November 18, 2022, the FDA issued a warning letter to Dr. David M. Lubeck/Arbor Centers for EyeCare. The FDA officials inspected Dr. Lubeck study and concluded that the investigator did not adhere to the FDA regulations governing the conduct of clinical investigations and the protection of human subjects. Specifically, the investigator failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with investigational new drugs that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].
The FDA argued that the investigational product used in combination with another drug comprised both a drug and a device components and was therefore a combination product within the meaning of section 503(g) of the FD&C Act (21 U.S.C. 353(g)).
Furthermore, the FDA underlined that because the primary mode of action of the investigational combination product was attributable to the product and because the product met the definition of a drug under section 201(g) of the FD&C Act, an IND was required for any clinical investigation of the investigational combination product used in such Protocol.
Among other important issues noted in this investigation was that the investigator did not wait the 30 days to enroll subjects in the study. An IND does not go into effect upon FDA’s receipt of the IND submission. Rather an IND generally goes into effect 30 days after FDA receives the application, or on earlier notification by FDA that the clinical investigation in the IND may begin (21 CFR 312.40(b)). The FDA emphasized that FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation that must be conducted under an IND in accordance with 21 CFR 312.40.
For more details about the inspection of this study and the findings of the FDA please review the Warning Letter to Dr. Davd M. Lubeck.
Developing a Mobile Health App?
Updated FTC-HHS online tool helps developers understand which federal laws apply
The Federal Trade Commission (FTC) in conjunction with the Department of Health & Human Services (HHS) Office for Civil Rights (OCR), the HHS Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA) have updated the Mobile Health App Interactive Tool. This tool is designed to help developers of health-related mobile apps understand what federal laws and regulations might apply to them. The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance tool will point the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the 21st Century Cures Act and ONC Information Blocking Regulations.
Developers and others seeking more information about how the HIPAA Rules might apply to their health apps should visit OCR’s HIPAA and Health Apps page, which contains information on how HIPAA applies to a range of example health app scenarios and offers key questions to consider in determining when HIPAA’s regulations cover a particular health app.
IRB Forms – Update
The following forms were updated in the IRB website:
- Sample Cover Letter for a Survey Study.docx (09/02/2022)
- Application Checklist for Initial and Continuing Review Full Board.docx (09/02/2022 – New Contact Information for Institutional Biosafety Committee )
- Application Checklist – Single Patient Expanded Access .docx(9/22/2022)
- Request for Exemption Form .doc(09/30/2022)
- Guidance for Completing Continuation Form.docx (10/12/2022)
- Guidance for Preparing a Chart Review Study .docx(10/12/2022)
- HIPAA Authorization to Use and Disclose – Spanish.doc (11/7/2022)
The following forms were added to the IRB website:
- Instructions for Facilitated Review for Collaborative Research with Neighboring Facility .docx(10/12/2022)
The following educational resources were added to the IRB website:
- NIH Policy for Data Management and Sharing (effective 1/25/2023)
- NIH Guide for Writing a Data Management & Sharing Plan
- Data Storage Finder (tool from Cornell University)
National Institute of Health (NIH) Policy for Data Management and Sharing
The National Institute of Health (NIH) has posted a one-page handout “The Who, What, Where and When of the NIH Data Management and Sharing (DMS) Policy” summarizing the most important information for investigators regarding the NIH Policy for Data Management and Sharing. Click on the image to go to their website and explore the info/links in the handout.
The University of Pennsylvania has shared the following resources on its website to aid investigators to comply with the National Institute of Health (NIH) Policy for Data Management and Sharing
NIH’s checklist that walks researchers through the elements of a DMSP
NIH is constantly updating its FAQ page on the DMSP. Check back for your questions.
Includes NIH webinar recordings and registration information for upcoming presentations.
Provides points to consider and sample language for informed consent documents of research studies which plan to store and share data and/ or biospecimens for future use.
Penn Libraries uses DMPTool to assist with writing data management plans. DMPTool is a resource researchers can use to draft data management plans. The new NIH DMSP template is available in the tool. We can provide comments on your DMSP if you need assistance. See our contact information on this page.
The National Institute of Mental Health (NIMH) has developed four example DMSPs that are consistent with NIMH and NIH requirements.
NIH institutes and centers may have other data sharing requirements in addition to the NIH DMS Policy. Make sure to read your applicable policy carefully.
A comprehensive listing of all NIH activity codes that generally require applicants to submit a Data Management & Sharing Plan
Provides an overview of ICPSR’s NIH funded archives and recommendations for designating ICPSR for your data to meet the requirements of the NIH DMSP.
Created by librarians and other research support professionals, this working group has created a variety of resources that researchers can use to prepare for the NIH DMS Policy implementation. Resources include glossaries, a DMSP checklist for researchers, and an example DMSP for the 2023 expectations.
Recent article on the NIH DMSP policy that covers 10 key recommendations for creating a DMSP that is both maximally compliant and effective.
Research Data & Digital Scholarship Data Sharing Services
Cornell University has excellent resources and tools on its website to aid investigators to comply with the National Institute of Health (NIH) Policy for Data Management and Sharing.
In addition, the NIH National Library of Medicine has posted the following resources:
Office of Human Research Protection (OHRP) Luminaries Lectures Series
Educational Resources for Investigators
The Office of Human Research Protection Luminaries Lectures Series features videos by esteemed individuals with thought-provoking insights on diverse aspects of human research protections.
Some of the recently added videos are listed below. These videos are covering the challenges of research during public health emergencies and research studying usual care practices, as well as thoughts from representatives in the research community on how to promote diversity and engagement in research participation:
- “The Covid Drug Wars” – What We Learned from the Front Lines
- “Unusual Practices Masquerading as Usual Care”
- “Vulnerability, Justice, Equity, and Engagement: A Conversation About Public Health and Human Subjects Research”
Click here and start watching!
Changes in the HSPP/IRB
Administrative Manager and Deputy Director of HSPP: Julia Blair has been named Administrative Manager of the HSPP, after filling the role on an interim basis since June following Deb Gibb’s retirement. She can be reached at firstname.lastname@example.org and (860) 679-7555.