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Research Compliance Chronicle: June 2025 Edition

Written by

Tasha Mohseni

in

,

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.

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Time to rewind June 2025:

Government agencies

Senate Committee of Appropriations

Murray, DeLauro, Baldwin Blast Director Bhattacharya for Terminating Thousands of Active NIH Grants, Upending Research, Threatening Patient Treatment

  • A letter to National Institutes of Health (NIH) Director Dr. Jayanta Bhattacharya calling out the Trump administrationโ€™s 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:
    • โ€œAs 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

NIH Director Commits to Providing Detailed List of Total Staff Reductions at NIH By End of Day; Senator Murray Grills Director on Cuts to Clinical Trials, Grant Terminations

Senate Committee of Health, Education, Labor, and Pensions (HELP)

NEWS: Sanders Statement on RFK Jr. Firing Vaccine Experts at CDC

  • 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 Trumpโ€™s backing, heโ€™s 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 Kennedyโ€™s dangerous war on science. It cannot stand.”

NEWS: Sanders, King Introduce Bill to Ban Prescription Drug Ads

  • 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, โ€œThe 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€
  • The bill text is available for review: S.2068

NEWS: Sanders Calls for Bipartisan Investigation into Secretary Kennedyโ€™s Vaccine Committee Firings at CDC

  • 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:
    • โ€œNow 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

Office of Science Technology and Policy (OSTP)

OSTP Issues Agency Guidance for Gold Standard Science

  • Directly from the article:
    • Director Kratsios says that โ€œthe 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
      • Without conflicts of interest
    • Agency implementation

CMS: Federal Register

Notices

Agency Information Collection Activities: Proposed Collection; Comment Request (2025-11979)
  • 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

FDA: Guidance Documents

Transfer of a Premarket Notification (510(k)) Clearance โ€“ Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff

  • 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

M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

  • 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

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

  • 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

Post-Warning Letter Meetings Under GDUFA

  • 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 facilityโ€™s 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

Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry

  • 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

Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry

  • FDA issued the revised draft guidance to describe the Agencyโ€™s thinking regarding:
    • Its use of Remote Regulatory Assessments (RRAs),
    • To help increase the industryโ€™s understanding of voluntary and mandatory RRAs, and
    • To facilitate FDAโ€™s process for conducting remote assessments for FDA-regulated products outside of the COVID-19 public health emergency
  • The final guidance is being issued consistent with FDAโ€™s good guidance practices regulation (21 CFR 10.115)
  • Comments may be submitted at any time related to this final guidance document

Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry

  • 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.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff

  • This document provides FDAโ€™s 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

FDA: Press Releases

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

  • Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency
  • The models don’t train on data submitted by regulated industry
    • Which should safeguard the sensitive research and data handled by FDA staff
  • Elsa is already being used to:
    • Accelerate clinical protocol reviews,
    • Shorten the time needed for scientific evaluations, and
    • Identify high-priority inspection targets
  • You can also view the video footage here: FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

FDA to Issue New Commissionerโ€™s National Priority Vouchers to Companies Supporting U.S. National Interests

  • 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 sponsorโ€™s 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
  • There is also a FAQ available: FAQs: Commissionerโ€™s National Priority Voucher Program

FDA Halts New Clinical Trials That Export Americansโ€™ Cells to Foreign Labs in Hostile Countries for Genetic Engineering

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

  • 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 โ€œEliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.โ€
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FDA: Federal Register

Proposed Rules: Hematology and Pathology Devices:

Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product

Rules: Medical Devices

Immunology and Microbiology Devices; Classification of the Device to Detect Bacterial Protease Activity in Chronic Wound Fluid
Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
Exemptions from Premarket Notification: Class II Devices; Clinical Electronic Thermometers
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities from Patients with Hematologic Malignancies
Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections
Radiology Devices; Classification of the Cream for X-Ray Attenuation

Notices

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
Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Epinephrine (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use
Food and Drug Administration’s Adverse Event and Product Experience Reporting Program
  • Comments must be submitted for review by Friday 7/25/2025.
Abbreviated New Animal Drug Applications
  • Comments must be submitted for review by Friday 8/15/2025.
Export of Medical Devices; Foreign Letters of Approval
  • Comments must be submitted for review by Friday 8/15/2025.
Medical Device Accessories
  • Comments must be submitted for review by Friday 8/15/2025.
Postmarket Surveillance of Medical Devices
  • Comments must be submitted for review by Friday 8/15/2025.
Electronic Submissions of Medical Device Registration and Listing
  • Comments must be submitted for review by Tuesday 8/19/2025.
Change in Federal Payment and Collection Options

HHS: Federal Register

Agency Information Collection Request. 30-Day Public Comment Request

  • 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 โ€œcheck 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.

HHS: Press Releases

HHS Takes Bold Step to Restore Public Trust in Vaccines by Reconstituting ACIP

  • 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 Trumpโ€™s Restoring 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

HRSA: Federal Register

Health Resources and Services Administration Uniform Data System

  • 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: Notices

NOT-OD-25-117: Request for Information (RFI): Inviting Comments on the NIH Artificial Intelligence (AI) Strategy

  • 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

NOT-OD-25-124: Notice of Rescission of Civil Rights Term and Condition of Award

  • Effectively immediately, NIH rescinds Guide Notice โ€œNotice of Civil Rights Term and Condition of Awardโ€ (NOT-OD-25-090)
    • NOT-OD-25-090 indicated to grant recipients during the terms of the financial assistance award to not:
      • Operate any programs that advance or promote DEI, DEIA, or discriminatory equity ideology in violation of Federal anti-discrimination laws; and
      • Engage in and will not during the term of this award engage in, a discriminatory prohibited boycott

NOT-OD-25-127: Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research

  • Effective immediately, the NIH will:
    • 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
  • This is with respect to the Executive Order on Improving the Safety and Security of Biological Research

NSF: Federal Register

Request for Information: Key Technology Focus Areas for the Directorate for Technology, Innovation and Partnerships

  • 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.

ORI: Policy Updates

Sample Policy & Procedures for Responding to Research Misconduct Allegations

Presidential actions

Enhancing National Security by Addressing Risks at Harvard University

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Proposed bills

H.R.3707 – NSF and USDA Interagency Research Act

  • 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
  • The bill text can be reviewed here: H.R.3707

H.R.3708 – No Place for LGBTQ+ Hate Act

H.R.3731 – Small Biotech Innovation Act

  • Congressman August Pfluger introduced legislation to protect innovative small biotech manufacturers from the Medicare drug price negotiation program
    • This act will establish a new exemption for small biotech companies based on the amount of revenue they reinvest in research and development
    • More information can be reviewed within the press release
  • The bill text can be reviewed here: H.R.3731

H.R.3744 – Research Integrity and Foreign Influence Prevention Act

  • Congressman Daniel Webster introduced the Research Integrity and Foreign Influence Prevention Act, legislation that amends the CHIPS and Science Act to safeguard Americaโ€™s research institutions from foreign influence and exploitation per this press release
  • The bill text can be reviewed here: H.R.3744

H.R.3836 – EO 14282 Act of 2025

H.R.3839 – EO 14155 Act of 2025

H.R.3955 – To improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies.

  • 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)
  • The bill text can be reviewed here: H.R.3955.
    • The following bill appears to be a senate companion bill (i.e., related to the introduced house bill): S.2062

H.R.4007 – To unfreeze and release funding for grant agreements of the National Institutes of Health, prohibit termination of such agreements for active and ongoing research, require the inclusion of termination clauses in such agreements, and prohibit termination of such agreements for no longer effectuating program goals or agency priorities.

  • Congresswoman Bonnie Watson Coleman introduced legislation to protect vital research being conducted by the NIH (per this press release)
    • The Preventing Halting of Active Research Act (PHARA)would:
      • Unfreeze and release funding for NIH contracts,
      • Prohibit termination of active research grants funding by the NIH, and
      • Peform termination clauses in grant contracts of the NIH
  • The bill text can be reviewed here: H.R.4007

H.R.4132 – To provide for digital communication of prescribing information for drugs (including biological products), and for other purposes.

  • 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
    • This was originally introduced in 2023; the original bill text is available for review.
  • The bill text can be reviewed here: H.R.4132
    • Please note that the bill text was obtained from the 2025 press release referenced above and not from Congress.gov
    • The following bill appears to be a senate companion bill (i.e., related to the introduced house bill): S.2027

H.R.4184 – To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes.

  • 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 can be reviewed here: H.R.4184
    • Please note that the bill text was obtained from the press release referenced above and not from Congress.gov

H.R.4203 – To amend the Internal Revenue Code of 1986 to allow certain wearable devices to be purchased using health savings accounts and other spending arrangements and reimbursement accounts.

I hope you found this post insightful and worth sharing with your colleagues!

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