The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Original title: “Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: “HR 10787: Access to Medical Supplies Act”

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicab

Original title: “Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalen

Original title: “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction”

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance.

Original title: “Challenges and Solutions in Lot-Level Food Traceability; Public Meeting”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

Original title: “Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams”

Spearheaded by vaccine skeptic Robert F. Kennedy Jr., the initiative will involve a new NIH clinic, an updated monitoring system and reimbursements for doctors who report suspected side effects.

Original title: “HHS launches new plan to strengthen vaccine injury research, reporting”

With the patent court siding with Halozyme, Merck faces restrictions on a product that won approval in Europe last year.

Original title: “Merck barred from making subcutaneous Keytruda in 8 European countries”

The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or "the Department") is issuing this final rule to remove regulations appearing in the Code of Federal Regulations (CFR). The regulations duplicate other regulations in the CFR, and have never been implemented by the IHS, and were referred to as "suspended" in a 1999 Federal Register Notice. Removing these regulations will not change the IHS's existing practices or authorities.

Original title: “Removal of Obsolete/Suspended Regulations”

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting r

Original title: “Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). The ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care del

Original title: “Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis”

The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or "the Department") is issuing this final rule to remove obsolete language appearing in the Code of Federal Regulations (CFR). The language refers to an outdated process for determining what the IHS will charge for care to non-IHS-beneficiaries. Eliminating this obsolete language will not change IHS's existing practices or authorities.

Original title: “Removal of Obsolete Portion of Regulation Relating to Care and Treatment of Ineligible Individuals”

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice did not include the determination that the abbreviated new drug applications (ANDAs) referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also determined to be withdr

Original title: “Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction”

The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is build

Original title: “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information”

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that FAYUVI (rebisufligene etisparvovec-hopf),

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf)”

These final rules set forth requirements that amend the regulations under the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code regarding price transparency reporting requirements for non- grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage. Specifically, these final rules are intended to improve the standardization, accuracy, and accessibility of public

Original title: “Transparency in Coverage”

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to

Original title: “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems”

Referred to the Committee on Education and Workforce, and in addition to the Committee on Energy and Commerce, 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: “HR 10760: To establish a multiagency Middle School Mental Health Task Force at the Department of Education and the Department of Health and Human Services.”

The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and ef

Original title: “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry”