Sandra Sather
FDA Releases Final Guidance on Decentralized ...

11/18/2024

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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).

FDA Releases Final Guidance on Decentralized Clinical Trials
Sandra Sather
FDA Issues Warning Letter Regarding Patient ...

10/22/2024

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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.

FDA Issues Warning Letter Regarding Patient Overdose
Guest User
FDA Updates Guidance to Address the Spread of ...

10/10/2024

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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.

FDA Updates Guidance to Address the Spread of Misinformation
Sandra Sather
Real-World Data and Evidence Generation with ...

10/01/2024

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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.

Real-World Data and Evidence Generation with Dr. Hilary Marston
Sandra Sather
New Draft Guidance on Predetermined Change ...

09/18/2024

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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA FINAL Guidance for Electronic Health Record Data Released!

7/24/2018

The Food and Drug Administration (FDA) published a guidance document on July 18, 2018, entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry,” which finalizes the draft guidance released in May 2016. The purpose of the guidance is to support industry in use of electronic data capture systems (EDC) and electronic health records (EHR) while protecting the confidentiality, integrity, and security of data. The guidance aligns with the 21st Century Cures Act, which prompted the FDA to publish guidance for use of “real-world evidence” in regulatory activities.

Remote Access to PHI

7/13/2018

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a guidance 21st Century Cures Act Guidance: Remote Access to PHI for Activities Preparatory to Research in December 2017 to clarify how protected health information (PHI) may be used via remote electronic access for research preparation activities.

Background:

  • The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule found in 45 CFR Part 160 and Subparts A and E of Part 164 describe how PHI may be used for research by a covered entity.

FDA Drafts Guidance for Consideration for Inclusion of Pregnant Women in Clinical Trials – Part 3

6/9/2018

In Part 1 of our blog series about Food and Drug Administration (FDA)’s draft guidance entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background, and in Part 2 we discussed ethical considerations. Now in Part 3, we will discuss other considerations for enrolling pregnant women in clinical trials.

FDA Drafts Guidance for Consideration for Inclusion of Pregnant Women in Clinical Trials – Part 2

6/7/2018

In Part 1 of our blog series about the Food and Drug Administration (FDA)’s draft guidance on inclusion of pregnant women in clinical trials entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background behind the draft guidance. The FDA identified some risk-based ethical considerations for inclusion of pregnant women, including availability of other treatment options, the type and severity of the disease or condition being treated, and the stage of development of the drug (approved or investigational). The FDA recommends the sponsor consult an ethicist to evaluate the trial design, and the sponsor should have discussions with the FDA, including bioethics and maternal health experts, early in the development stage. In any case, the sponsor must follow the regulations for human subject protections.