EdTech Discovery
Argus

Named after the hundred-eyed watchman of Greek myth, Argus watches the education landscape: spotting new opportunities, pressure-testing the ventures we're building, and tracing every read back to the real-world signals behind it.

Updated Aug 31, 2026 · 36 ideas · 18349 signals

Signals

The evidence library: the raw signals the pipeline is watching across the education ecosystem. Every idea is built from these.

regulation Aug 28, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic collection of information through which we intend to seek insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services.

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regulation Aug 28, 2026
Federal Register: Health & Human Services

Federal Independent Dispute Resolution Operations; Correction

This document corrects typographical errors and omissions in the final rule that appeared in the June 4, 2026, Federal Register titled "Federal Independent Dispute Resolution Operations" (referred to hereafter as the "IDR final rule"). The effective date of the IDR final rule was August 3, 2026.

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regulation Aug 28, 2026
Federal Register: Health & Human Services

Agency Forms Undergoing Paperwork Reduction Act Review

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regulation Aug 28, 2026
Federal Register: Health & Human Services

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Death Index (NDI). The NDI allows NCHS to collect mortality data to support epidemiological research and to furnish mortality information to approved public health and medical investigators.

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regulation Aug 28, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The National Health Service Corps Loan Repayment Programs OMB No. 0915-0127-Revision

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Center For Scientific Review; Notice of Closed Meetings

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Notice of Award of a Single Source Cooperative Agreement To Fund Elizabeth Glaser Pediatric AIDS Foundation

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $750,000 for Federal Fiscal Year 2026 funding to Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), subject to the availability of funds. The award supports activities to improve HIV care and treatment for children and eliminate mother-to-child HIV transmission faster, working with faith-based organizations (FBOs), faith-affiliated health facilities, and community-based organizations (CBOs), which are trusted providers in many high-burden communities. Funding amounts for years 2-5 will be set at continuation.

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Notice of Award of a Sole Source Cooperative Agreement To Fund Vietnam Administration of Medical Services, National Institute of Medical Research, and ASEAN-Plus Field Epidemiology Training Network Foundation

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces three separate awards to fund Vietnam Administration of Medical Services (VAMS), National Institute of Medical Research (NIMR), and ASEAN+3 FETN Foundation. For Vietnam Administration of Medical Services (VAMS), the award is approximately $2,000,000 for Federal Fiscal Year (FFY) 2026, with an expected total funding of approximately $10,000,000. For National Institute of Medical Research (NIMR), the award is approximately $2,000,000 for FFY 2026, with an expected total funding of approximately $10,000,000. For ASEAN+3 FETN Foundation, the award is approximately $500,000 in FFY 2026, with an expected total funding of approximately $2,500,000. The total 5-year period amount for the three recipients is $22,500,000, subject to the availability of funds. Funding amounts for years 2-5 will be set at continuation. The awards will support activities to protect Americ

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Center for Scientific Review; Amended Notice of Meeting

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Center for Scientific Review; Notice of Closed Meetings

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information col

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661" (91 FR 31462) (the "May 2026 Notice"), as previously extended by the notice published in the Federal Register on June 26, 2026 (91 FR 38717) (the "June 2026 Notice"), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.

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regulation Aug 27, 2026
Federal Register: Health & Human Services

Center for Scientific Review; Notice of Closed Meetings

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regulation Aug 26, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on allegations of regulatory misconduct voluntarily submitted to the Center for Devices and Radiological Health (CDRH).

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regulation Aug 26, 2026
Federal Register: Health & Human Services

International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments

The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the United States to the Expert Committee on Drug Dependence (ECDD) regarding the abuse liability and diversion of these drugs. The ECDD will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).

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regulation Aug 26, 2026
Federal Register: Health & Human Services

Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.

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regulation Aug 26, 2026
Federal Register: Health & Human Services

Meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that an in-person meeting is scheduled to be held for the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB).

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regulation Aug 26, 2026
Federal Register: Health & Human Services

Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period

The Office of the Assistant Secretary for Health (OASH or we) is extending the comment period to solicit input and comments on a Request for Information (RFI) on a proposed threshold for 7- hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act that appeared in the Federal Register of July 6, 2026. Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General. We are taking this action in response to a request for an extension to allow interested persons additional time to provide comments and input.

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regulation Aug 26, 2026
Federal Register: Education Dept

Notice Inviting Publishers To Submit Tests for a Determination of Suitability for Use in the National Reporting System for Adult Education

The Secretary of Education invites publishers to submit tests for review and approval for use in the National Reporting System for Adult Education (NRS) and announces the date by which publishers must submit these tests. This notice relates to the approved information collection under OMB control number 1830-0567.

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regulation Aug 25, 2026
Federal Register: Health & Human Services

National Heart, Lung, and Blood Institute; Notice of Meeting

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regulation Aug 25, 2026
Federal Register: Health & Human Services

National Heart, Lung, and Blood Institute; Notice of Closed Meeting

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regulation Aug 25, 2026
Federal Register: Health & Human Services

Office of the Director, National Institutes of Health; Notice of Meeting

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regulation Aug 25, 2026
Federal Register: Health & Human Services

National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting

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regulation Aug 25, 2026
Federal Register: Health & Human Services

Request for Information (RFI): Request for Information on New and Emerging Areas of Science Relevant to the NIDCD Mission, To Inform an Update of the NIDCD Strategic Plan for 2028-2032

The National Institute on Deafness and Other Communication Disorders (NIDCD) seeks comments and suggestions from the public in response to one question: Are there new and emerging areas of science with the potential to impact the health and wellbeing of people with disorders of hearing, balance, taste, smell, voice, speech and language that are not reflected in the themes and goals of the NIDCD Strategic Plan? Responses to this RFI will be considered as NIDCD updates its current strategic plan.

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regulation Aug 25, 2026
Federal Register: Education Dept

Privacy Act of 1974; Matching Program

Pursuant to the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 and the Computer Matching and Privacy Protection Amendments of 1990 (Privacy Act), and Office of Management and Budget (OMB) guidance on the conduct of matching programs, notice is hereby given of the establishment of a matching program between the U.S. Department of Education (Department) and the U.S. Department of the Treasury, Bureau of the Fiscal Service (Fiscal Service). The matching program allows Fiscal Service to provide services relating to the identification, prevention, and/or recovery of improper payments pursuant to the Do Not Pay program operating under 31 U.S.C. 3554.

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regulation Aug 25, 2026
Federal Register: Education Dept

Privacy Act of 1974; Matching Program

This matching program will assist the U.S. Department of Education (Department or ED) in its obligation to ensure that borrowers whom the Social Security Administration (SSA) identifies as disabled with Medical Improvement Not Expected (MINE) status and who either owe balances on or who have had any of loans made under Title IV of the Higher Education Act of 1965, as amended (HEA) written off due to default for the Federal Perkins Loan Program (20 U.S.C. 1087aa et seq.), the William D. Ford Federal Direct Loan Program (20 U.S.C. 1087a et seq.), the Federal Family Education Loan (FFEL) Program (20 U.S.C. 1071 et seq.), or the Federal Insured Student Loan (FISL) Program (20 U.S.C. 1071 et seq.) or with Teacher Education Assistance for College and Higher Education (TEACH) Grant service obligations (referred to collectively herein as "Title IV loans") more efficiently and effectively are able to obtain Total and Permanent Disability (TPD) discharges of their Title IV loans.

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regulation Aug 25, 2026
Federal Register: Education Dept

Final Waiver and Extension of the Project Period With Funding-Elementary and Secondary Education Act of 1965, as Amended, Title VI, Part B, Native Hawaiian Education

The Secretary waives the requirements in the Education Department General Administrative Regulations (EDGAR) that generally prohibit project period extensions involving the obligation of additional Federal funds. The final waiver and extension would allow 21 projects under Assistance Listing Number (ALN) 84.362A to receive funding for up to one additional 12-month period, not to exceed September 30, 2027.

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regulation Aug 24, 2026
Federal Register: Health & Human Services

Government Owned Invention Available for License: T Cell Receptors Targeting HPV 6 or HPV 11

The National Cancer Institute (NCI) seeks research co- development partners and/or licensees for a collection of T cell receptors (TCRs) that specifically target HPV 6 or HPV 11 antigens.

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regulation Aug 24, 2026
Federal Register: Health & Human Services

Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.

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regulation Aug 24, 2026
Federal Register: Health & Human Services

Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.

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regulation Aug 24, 2026
Federal Register: Health & Human Services

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066

The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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regulation Aug 24, 2026
Federal Register: Health & Human Services

Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making

The Department of Health and Human Services (HHS or the Department), in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order of August 10, 2026, "Delivering Gold Standard Childhood Vaccine Recommendations for Americans," seeks public comment on whether the categories currently used in Federal vaccine recommendations are adequate. Those categories are routine (universal) recommendations, risk-based recommendations, and recommendations based on shared clinical decision-making, also referred to as individual-based decision-making. The Department seeks comment on these categories and whether additional or different categories should be adopted. The Department further seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor

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regulation Aug 24, 2026
Federal Register: Education Dept

Education Department General Administrative Regulations

The Secretary of Education proposes to amend the Education Department General Administrative Regulations (EDGAR) and other provisions in 2 CFR parts 3474 and 3485 to update the regulations and better align them with other U.S. Department of Education (Department) regulations and procedures, and to include technical updates from the Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards published in the Federal Register on April 22, 2024. The Department intends to finalize these regulations in late 2026.

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2028, expiration date.

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information col

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information col

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Center for Scientific Review; Notice of Closed Meetings

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Government Owned Invention Available for License: Matched Patient-Derived 3D Isocitrate Dehydrogenase (IDH)-Mutant Glioma Cell Lines for Modeling Malignant Transformation

The National Cancer Institute (NCI) seeks licensees for matched patient-derived 3D Isocitrate Dehydrogenase (IDH)-mutant glioma cell lines, 403L and 403H, generated from the same patient before and after malignant transformation from WHO grade 2 to WHO grade 4 disease. This research material provides an opportunity to study IDH-mutant glioma progression, temozolomide-associated hypermutation, invasion, metabolism, and treatment resistance.

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection; Comment Request

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the reinstatement with change of the previously approved information collection project "AHRQ Research Reporting System (ARRS)" OMB No 0935-0122. This information collection was previously published in the Federal Register on June 17, 2026, and allowed 60 days for public comment. AHRQ did not receive any comments. The purpose of this notice is to allow an additional 30 days for public comment. The package expired on July 31, 2027.

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regulation Aug 21, 2026
Federal Register: Health & Human Services

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Faculty Loan Repayment Program, OMB No. 0906-0082-Revision

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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regulation Aug 21, 2026
Federal Register: Education Dept

Agency Information Collection Activities; Comment Request; Higher Education Act (HEA) Title II Report Cards on State Teacher Credentialing and Preparation

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).

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regulation Aug 21, 2026
Federal Register: Education Dept

Agency Information Collection Activities; Comment Request; Consolidated Annual Report (CAR) for the Carl D. Perkins Career and Technical Education Act of 2006

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).

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regulation Aug 21, 2026
Federal Register: Education Dept

National Advisory Committee on Institutional Quality and Integrity; Notice of Meeting

This notice sets forth the agenda, time, and instructions to access or participate in the September 23 & 24, 2026 meeting of NACIQI and provides information to members of the public regarding the meeting, including requesting to make written or oral comments. Committee members will meet in-person. Agency representatives have the option to meet in-person or virtually, and public attendees will participate virtually. The notice of this meeting is required under 5 U.S.C. Chapter 10 (commonly known as the Federal Advisory Committee Act) and Section 114(d)(1)(B) of the Higher Education Act (HEA) of 1965, as amended.

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regulation Aug 21, 2026
Federal Register: Education Dept

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Presidential Cybersecurity Education Award

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a reinstatement without change of a previously approved information collection request (ICR).

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Privacy Act of 1974; System of Records

The Department of Health and Human Services (HHS) is delaying the effective date of the new routine use under the modified system of records maintained by the Office of Family Assistance (OFA) within HHS' Administration for Children and Families (ACF), System No. 09-80-0375, Temporary Assistance for Needy Families (TANF) Data that appeared in the Federal Register of June 23, 2026.

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Center for Scientific Review; Notice of Closed Meetings

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Center or Scientific Review; Notice of Closed Meetings

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on "Potency Assurance for Cellular and Gene Therapy Products" with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.

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regulation Aug 20, 2026
Federal Register: Health & Human Services

Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal

The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2028, expiration date.

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