The Food and Drug Administration (FDA, the Agency, or we) is announcing that we are granting an exemption for certain cottage cheese products from the requirements of the rule titled "Requirements for Additional Traceability Records for Certain Foods" (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations.

Original title: “Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance”

The Clinical Center (CC), an institute/center of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), published a Notice in the Federal Register on February 13, 2026. That notice requires a correction in the SUPPLEMENTARY INFORMATION section.

Original title: “Government Owned Inventions Available for License: Gait Assistance Systems and Methods of Control Thereof; Correction”

Referred to the Committee on the Judiciary, and in addition to the Committees on Education and Workforce, Energy and Commerce, Financial Services, Oversight and Government Reform, Armed Services, Veterans' Affairs, and House Administration, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HRES 1058: Recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic security.”

This report describes receipt of COVID-19 antiviral prescriptions among outpatients aged 65 and older from June 1, 2023-September 30, 2025.

Original title: “COVID-19 Antiviral Prescription Receipt Among Outpatients Aged ≥65 Years — United States, June 1, 2023–September 30, 2025”

This report describes respiratory virus activity in the United States during July 1, 2024-June 30, 2025.

Original title: “Respiratory Virus Activity — United States, July 1, 2024–June 30, 2025”

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

Original title: “FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals”

The FDA’s drug review process can often be "unpredictable," and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.

Original title: “Cassidy Names Areas of Improvement for FDA’s Regulatory ‘Black Box’”

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.

Original title: “It’s Official: FDA Will Now Default to One Clinical Trial for Drug Applications”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 7489: Georgetown VA Community-Based Outpatient Clinic Authorization Act of 2026”

Read twice and referred to the Committee on Finance.

Original title: “S 3730: Emergency Medical Services Reimbursement for On-Scene Care and Support Act”

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceu

Original title: “Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community”

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Original title: “Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area (Hugh Chatham Memorial Hospital, Inc.)”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Insprucker for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Insprucker was convicted of one felony count under Federal law for conspiracy to introduce a misbranded drug in interstate commerce with the intent to defraud and mislead. The factual basis supporting Mr

Original title: “Justin Insprucker: Final Debarment Order”

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Original title: “Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area (Lexington Medical Center)”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sherri Insprucker for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Insprucker was convicted of one felony count under Federal law for conspiracy to introduce a misbranded drug in interstate commerce with the intent to defraud and mislead. The factual basis supporting Ms

Original title: “Sherri Insprucker: Final Debarment Order”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sherrie R. McCain for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. McCain was convicted of a felony under Federal law for introduction into interstate commerce of a misbranded drug. The factual basis supporting Ms. McCain's conviction, as described below, is conduct rel

Original title: “Sherrie R. McCain: Final Debarment Order”

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to ExThera Medical Corporation, for the Seraph 100 Microbind Affinity Blood Filter (Seraph 100). FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.

Original title: “Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SYMVESS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS”

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: 065" (Recognition List Number: 065), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical d

Original title: “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065”

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the methods of analysis regulation, which describes an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is issuing this action because the existing regulation is no longer necessary.

Original title: “Revocation of Methods of Analysis Regulation”