Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.
Updated on Friday, July 4, 2025 to remove duplicate FDA guidance document entry.
Updated on Saturday, July 5, 2025 to include S.2062 bill text.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators!280+ subscribers and counting!
I hope everyone has been doing well! It’s time for another monthly recap of research and compliance news. For those who have not read this type of blog post before:
Research Compliance Chronicle:
At the beginning of each month, I will summarize key regulatory news related to research compliance from the previous month.
Consider this your one-stop shop for “ICYMI regulatory updates”!
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
A letter to National Institutes of Health (NIH) Director Dr. Jayanta Bhattacharya calling out the Trump administrationโs decision to terminate at least 2,370 active NIH grants
The letter demands that the NIH provides:
The legal authority being used to terminate grants,
A comprehensive list of grant cancellations,
Details on the impact to clinical trials, and
The criteria used for termination decisions
The following quote stood out to me upon review:
โAs research institutions, scientists, and trainees struggle with the loss of staff, jobs, and income, patients enrolled in NIH-funded clinical trials face abrupt cancellations or delays in lifesaving treatment.โ
You can review the contents of the letter here: Letter
Copied directly from the press release, Sanders released the following quote:
“Firing independent vaccine experts is a dangerous, unprecedented move that will make it harder for the American people to access vaccines that are safe, effective, and essential to saving lives. For decades, Secretary Kennedy has spread lies and conspiracy theories about vaccines. Now, with Trumpโs backing, heโs doubling down on misinformation that will lead to preventable illness and death. At a time when we should be strengthening trust in science and expanding access to health care, this administration is doing the exact opposite. This is a continuation of Trump and Kennedyโs dangerous war on science. It cannot stand.”
Sanders introduced the End Prescription Drug Ads Now Act, legislation that would ban prescription drug advertising on television, radio, print, digital platforms and social media
Per the press release, โThe End Prescription Drug Ads Now Act would prohibit direct-to-consumer advertising of pharmaceutical drugs to protect people. This bill is a great step to ensure that patients are getting the best information possible and from the right source: their providers and not biased advertisements.โ
RFK Jr. fired every member of the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC)
ACIP is a federal advisory group of medical and public health experts who make evidence-based recommendations on which vaccines should be administered to whom and when
Though all quotes are notable, the following stood out:
โNow the fear is that the ACIP will be filled up with people who know nothing about vaccines except suspicion.โ
Sanders wrote a letter to HELP Chairman Bill Cassidy, calling for an immediate bipartisan investigation into these terminations, which can be reviewed here: Dear Chairman Cassidy letter
Director Kratsios says that โthe need for Gold Standard Science stems from the crucial role of scientific integrity in tackling complex challenges to address critical areas, such as energy innovation and national security. In an age of rapid technological progress and heightened public scrutiny, federal science, and its use in federal decision making, must be beyond reproach.โ
The full memo is available for review. In summary, the memo discusses:
The importance of gold standard science
The tenets of gold standard science
Reproducible
Transparent
Communicative of error and uncertainty
Collaborative and interdisciplinary
Skeptical of its findings and assumptions
Structured for falsifiability of hypotheses
Subject to unbiased peer review
Accepting of negative results as positive outcomes
The information collection requests pertain to the following:
Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request
Comments must be submitted for review by Friday 8/29/2025
This guidance provides information on FAQ regarding the transfer or sale of a premarket notification (510(k)) clearance from one 510(k) holder to another
Comments must be submitted for review by Monday 8/4/2025
The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information
Comments must be submitted for review by Monday 7/7/2025
The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information
Comments must be submitted for review by Monday 7/7/2025.
This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA)
Comments may be submitted at any time related to this final guidance document
This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA)
This guidance describes:
The process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facilityโs ongoing remediation efforts to address current good manufacturing practice (CGMP) deficiencies described in a warning letter,
How to prepare and submit a complete meeting package, and
How FDA intends to conduct the Post-Warning Letter Meeting
Comments may be submitted at any time related to this final guidance document
This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively
The revision also provides stability related guidance for product categories such as:
Advanced therapy medicinal products,
Vaccines, and
Other complex biological products including combination products that were not previously covered under the existing stability guidance documents
This guidance document is not open for comment at this time
This guidance outlines the requirements, recommendations, and best practices for UDI labeling and for submission of information to the Global Unique Device Identification Database (GUDID) for such combination products
Comments must be submitted for review by Wednesday 9/24/2025.
This document provides FDAโs recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk
These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats
Comments may be submitted at any time related to this final guidance document
The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsorโs final drug application submission
To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application
They must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review
The FDA announced an immediate review of new clinical trials which involved sending American citizensโ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into US patients
This was sometimes without their knowledge or consent
This action is part of a broader national effort to implement Executive Orders 14117 and 14292:
The FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies
These are gene therapies that are currently approved to treat blood cancers (e.g., myeloma and certain types of leukemia and lymphoma)
For those who are unaware, REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks
It is worth noting that these products will continue to be subject to safety monitoring, through adverse event reporting requirements in accordance with regulations (21 CFR 600.80)
A key quote from this press release states โEliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.โ
For all notices listed below for public comment, the FDA invites comments on these topics:
Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
Ways to enhance the quality, utility, and clarity of the information to be collected; and
Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology
The proposed changes to the Federalwide Assurance (FWA) Form include:
Removing the Pre-2018 Common Rule requirement that institutions provide a statement of ethical principles;
Removing the Pre-2018 Common Rule requirement that an institution designate one or more IRBs to review the research to which the FWA applies;
Removing โcheck the boxโ, or the option for U.S. institutions to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46, to all of an institution’s nonexempt human subjects research regardless of the source of support; and
Eliminating the requirement for institutions outside the U.S. to provide procedural standards they apply for human subjects research when assuring compliance with the Terms of the Federalwide Assurance
Comments must be submitted for review by Monday 7/14/2025.
As mentioned above, ACIP is a federal advisory group of medical and public health experts who make evidence-based recommendations on which vaccines should be administered to whom and when
President TrumpโsRestoring Gold Standard Science executive order, the new ACIP members will ensure that government scientific activities are informed by the most credible, reliable, and impartial scientific evidence available
ACIP held their first meeting (per the Federal Register) on Wednesday, June 25, 2026
The request for comment pertains to HRSA Uniform Data System (UDS), with one change pertaining to the removal of patients by sexual orientation and gender identity data collection
Comments must be submitted for review by Wednesday 7/23/2025.
NIH invites public comment on themes, pillars, and specific actions that should shape the forthcoming NIH AI Strategic Plan and its early one-year action plan
Comments must be submitted for review by Tuesday 7/15/2025
Terminate funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research conducted by foreign entities in countries of concern or foreign countries where there is not adequate oversight; and
Suspend all other funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research at least until implementation of the new policy described in Section 4(a) of the Executive Order
The public may provide responses to one or as many questions as they choose, keeping the response to each question to four sentences or fewer with respect to the potential updates to the NSF key technology focus areas:
Artificial intelligence, machine learning, autonomy, and related advances
High performance computing, semiconductors, and advanced computer hardware and software
Quantum information science and technology
Robotics, automation, and advanced manufacturing
Natural and anthropogenic disaster prevention or mitigation
Advanced communications technology and immersive technology
Biotechnology, medical technology, genomics, and synthetic biology
Data storage, data management, distributed ledger technologies, and cybersecurity, including biometrics
Advanced energy and industrial efficiency technologies, such as batteries and advanced nuclear technologies, including but not limited to for the purposes of electric generation
Advanced materials science, including composites 2D materials, other next-generation materials, and related manufacturing technologies
Comments must be submitted for review by Monday 7/21/2025.
Congressman Jim Baird introduced the NSF and USDA Interagency Research Act to strengthen a longstanding interagency research partnership between NSF and USDA to promote cross-cutting and collaborative research and development to enhance agricultural sustainability through advanced technological solutions
U.S. Representative Becca Balint launched a new effort to push back against the Trump Administrationโs assault on the rights and freedoms of LGBTQ+ Americans nationwide (according to this press release)
This act proposes to repeal the following executive orders targeting LGBTQ+ individuals:
Congressman Daniel Webster introduced the Research Integrity and Foreign Influence Prevention Act, legislation that amends the CHIPS and Science Act to safeguard Americaโs research institutions from foreign influence and exploitation per this press release
Representatives Angie Craig reintroduced bipartisan legislation to strengthen domestic medication supply chains and reduce American reliance on China for critical medications (per this press release)
Representative Diana Harshbarger reintroduced the bipartisan Prescription Information Modernization Act (per this press release)
This legislation would allow the FDA to move forward with a proposed rule allowing drug manufacturers to transmit prescribing information electronically to doctors and pharmacists, as opposed to printed copy, as currently required
Representative Mike Kelly announced the introduction of the Harley Jacobsen Clinical Trial Participant Income Exemption Act, legislation that aims to exempt all payments received by participants in clinical trials from being counted towards their gross income (per this press release)
The bill text is not available at this time (nor is there a current press release related to this proposed bill) – note that this bill was introduced Thursday, June 26, 2025
