Welcome to WCG’s comprehensive FDA Guidance Portal. Designed to keep you informed and ahead of the curve, this portal aggregates the latest FDA guidances, offering clear and concise summaries to help you quickly understand essential regulatory updates.
In addition to these summaries, you’ll find a wealth of expert-driven content — ranging from in-depth whitepapers to insightful webinars — that dives deeper into each guidance, providing actionable insights and best practices. Whether you’re a seasoned professional or new to regulatory affairs, our resource hub is your go-to destination for staying compliant and informed in the ever-evolving landscape of FDA regulations.
To understand why FDA’s changes in regulation take so long…
WCG’s Summaries and Insights:
Summary:
To comply with the 21st Century Cures Act, the Food and Drug Administration (FDA or USFDA) has released a Notice of Proposed Rulemaking (NPRM). This NPRM describes changes to FDA regulations to harmonize with the Common Rule regarding informed consent requirements. It describes the requirements for a “key information” section to be placed at the start of the consent form. This section should provide a summary of the most important information that may lead someone to decide whether to participate in a trial. FDA is also proposing to include three additional elements of informed consent, which have already been included in the revised Common Rule. IRBs, institutions, and investigators involved in the review and conduct of federally-funded research have already adopted many of these provisions in 2018 in the Common Rule, but other commercial sponsors and investigators should update consent form templates and other documents to comply with this proposed rule.
Date: 9/28/2022
Type: Proposed Rule
Docket #: FDA-2021-N-0286, 21 CFR 50, 21 CFR 56, 21 CFr 812
Our Coverage:
Revisiting the FDA’s Proposed Single IRB Mandate: Navigating Changes and Aligning for Success
VideosWhat Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?
WhitepapersHow WCG Is Preparing for FDA Harmonization with the Common Rule
Blog PostsWhat Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?
WhitepapersUnderstanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
VideosSummary:
On August 15, 2023, FDA published a final guidance entitled, “Informed Consent, Guidance for IRBs (Institutional Review Boards), Clinical Investigators, and Sponsors.” This final guidance supersedes the September 1998 guidance entitled “A Guide to Informed Consent” and replaces the July 2014 draft guidance “Informed Consent Information Sheet.” The final guidance references where the differences exist between FDA regulations and the 2018 Common Rule, where there are plans to update the regulations and how IRBs, investigators and sponsors might navigate the differences between the two processes in the meantime. This whitepaper provides a summary of the final guidance and offers insights into its value as a resource for IRBs, Investigators and sponsors when considering the informed consent process.
Date: 8/15/2023
Type: Final
Citation: Docket # FDA-2006-D-0031
Our Coverage:
What You Should Know About FDA Final Informed Consent Guidance
Blog PostsReviewing the FDA’s Proposed Informed Consent Rule Changes
WhitepapersIf My Study Includes Approved Drugs, When Do the Risks of Those Drugs Need to Be Disclosed in the Consent Form?
Blog PostsWhat Is Assent, When Provided by an Adult Participant Lacking Capacity? And What Are WCG’s Expectations and the Investigator’s Responsibilities?
Blog PostsFunction over Form: Assessing Different Consent Form Formats
WhitepapersSummary:
In July 2024, the Food and Drug Administration (FDA) released a draft guidance for industry entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The draft guidance is intended to help sponsors developing drugs to treat pediatric patients with inflammatory bowel disease and includes recommendations about the necessary components of clinical studies for the treatment of pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study design, efficacy considerations, and safety assessments.
Date: 7/10/2024
Type: Draft
Citation: Docket # FDA-2024-D-2682-0002
Our Coverage:
Unpacking the FDA’s Guidance on Developing Drugs for Treatment in Pediatric Inflammatory Bowel Disease
Blog PostsSummary:
On April 29, 2024, The FDA announced a final rule aimed at helping to ensure the safety and effectiveness of laboratory developed tests (LDTs). The rule amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. This whitepaper discusses a brief history of diagnostic assay oversight (or lack thereof) and provides support for the FDA’s decision to establish clear regulatory pathways for LDTs.
Date: 4/29/2024
Type: Final
Citation:
Our Coverage:
Sunsetting FDA Enforcement Discretion of Laboratory Developed Tests
Blog PostsSummary:
In March 2024, the Food and Drug Administration (FDA) revised its draft guidance for industry entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment”. This guidance applies specifically to trials targeting patients with early sporadic Alzheimer’s disease (AD), prior to the onset of overt dementia. The previous draft guidance published in 2018 required revisions due to the rapidly changing landscape of AD clinical trials, which are increasingly focusing on early disease stages. While cognitive and functional endpoints remain crucial, the 2024 guidance offers more flexibility in their application. Recognizing the challenges in capturing functional changes in early disease stages, the guidance supports the use of sensitive cognitive assessments and other innovative approaches to detect clinically meaningful changes, thus offering a more nuanced understanding of drug efficacy in this context.
Date: 3/11/2024
Type: Draft
Docket #: FDA-2013-D-0077
Our Coverage:
Comment on the revised FDA Industry Guidance for Early AD Drug Development: Implications for Clinical Outcomes Assessments
Blog PostsSummary:
This guidance is one in a series of guidances addressing eligibility for clinical trials of oncology drugs. Specifically, this guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status (PS).
Date: 4/24/2024
Type: Draft
Docket #: FDA-2024-D-1377
Our Coverage:
Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRB, and Clinical Investigators
Blog PostsCancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators
Blog PostsSummary:
On April 4, 2024, the National Institutes of Health released a finalized amendment to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). As noted in the Federal Register notice, the amendment goes into effect September 30, 2024. As of that date, certain genetically engineered cellular therapies will be subject to the NIH Guidelines and biosafety requirements outlined therein. This blog post provides additional details from our experts and insights about what the changes could mean for your research.
Date: 4/1/2024
Type: Final
Citation: 89 FR 24016
Our Coverage:
How New Changes to the NIH Guidelines Will Impact IBC Review
Blog PostsSummary:
This guidance provides recommendations to sponsors and investigators who are considering submitting a non-interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug.
Date: 3/1/2024
Type: Draft
Docket #: FDA-2023-D-5470
Our Coverage:
Is This an Interventional Clinical Trial or Observational Study? How- and Why- It Is Important to Write Protocols That Make This Distinction Clear
WhitepapersSummary:
The FDA has provided a question and answer document on Dietary Supplements. This whitepaper will examine what sponsors/investigators need to consider when designing a study with dietary supplements to ensure compliance with the FDA requirements. When reviewing a proposed study, the IRB applies the regulations that govern dietary supplements, as well as the regulations that govern drugs. Under current regulations, if the objective(s) of a clinical investigation of products lawfully marketed as dietary supplements meet the FDA’s definition of a health claim, an IND is usually required. However, if the objective(s) of the study are to assess the effect of a dietary supplement on the body’s structure, function, or mechanism of action, then an IND may not be required.
Date: 2/21/2024
Our Coverage:
Dietary Supplements: Regulations in Research Studies and IRB Considerations
Blog PostsSummary:
The release of the FDA’s draft guidance on Data Monitoring Committees (DMCs) aims to modernize and clarify expectations for DMC involvement in safeguarding participant well-being and ensuring trial integrity. Several topics are highlighted including risk/benefit assessment, maintaining independence and reducing bias, sharing oversight responsibilities, defining analyses, and utilizing unbiased statistical support. Potential benefits to the clinical trial industry include enhanced participant safety, increased study rigor and integrity, and reduced time to market.
Date: 2/13/2024
Type: Draft
Docket #: FDA-2001_D-0219
Our Coverage:
FDA Proposes Revamped Data Monitoring Committee Guidance: A Deep Dive into the Benefits for Clinical Trials
Blog PostsSummary:
FDA’s Path toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility” describes the DEPICT Act and its practical effect within the clinical trials space. The DEPICT Act requires the FDA to require clinical trial sponsors to submit Diversity Action Plans with their protocols for Phase III or other pivotal trials. This white paper further discusses the DEPICT Act’s effect on Sponsor responsibility and accountability as it pertains to the diversity of populations enrolled in their clinical trials. Recommendations are provided for the facilitation of the requirements of the DEPICT Act as well as recognition of some of the challenges ahead.
Date: 12/23/2023
Type: Final
Public Law No: 117-328
Our Coverage:
FDA’s Path Toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility
WhitepapersSummary:
In May 2023, The FDA issued a draft guidance on the topic of decentralized clinical trials for drugs, biological products, and Devices. This blog post seeks to assist sponsors/CROs in understanding the IRB’s requirements for submitting research locations for decentralized clinical trials.
Date: 5/1/2023
Type: Draft
Docket #: FDA-2022-D-2870
Our Coverage:
IRB Submission Requirements for Decentralized Clinical Trials
Blog PostsSummary:
On March 30, 2023, FDA and OHRP published a Draft Guidance that describes the process for referral of research involving children as subjects and not otherwise approvable by an IRB. The Draft Guidance describes the required documents that must be provided to FDA and identifies IRBs and institutions as the organizations that are expected to make the 21 CFR 50.54, 45 CFR 46.407 referrals. This blog post describes current WCG policy, which is to encourage sponsors, rather than the IRB, to initiate communication with, and directly interact with, FDA, OHRP or both regarding research on investigational products under an IND or IDE.
Date: 3/30/2023
Type: Draft
Docket #: FDA-2022-D-0142, 21 CFR 50.54, 45 CFR.407
Our Coverage:
What is the WCG IRB’s current process for reviewing research involving children as subjects that is not otherwise approvable by an IRB?
Blog PostsSummary:
To comply with the 21st Century Cures Act,1 the Food and Drug Administration (FDA or USFDA) has released two Notices of Proposed Rulemaking (NPRMs). One NPRM describes a potential requirement for multi-site research that is under FDA oversight to use a single IRB for the review of all study sites. Commercial sponsors and CROs should be prepared to address this new requirement if and when it is implemented, although the change should lead to less administrative burden on sponsors and CROs as only one IRB will review each study.
Date: 9/28/2022
Type: Proposed Rule
Docket #: FDA-2019-N-2175, 21 CFR 56
Our Coverage:
What Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?
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