While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.

Original title: “Trump Hits Drugmakers With 100% Tariff but Carve-outs Soften the Blow”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENCELTO 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; ENCELTO”

This notice acknowledges the approval of an application from the Accreditation Commission for Health Care Inc., for continued CMS approval as a national accrediting organization for hospice programs that wish to participate in the Medicare or Medicaid programs.

Original title: “Medicare and Medicaid Programs; Approval of Application by the Accreditation Commission for Health Care Inc. (ACHC) for Continued CMS-Approval of its Hospice Accreditation Program”

This notice announces our decision to approve the Accreditation Commission for Health Care Inc. (ACHC) for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.

Original title: “Medicare and Medicaid Programs: Application From the Accreditation Commission for Health Care Inc. (ACHC) for Continued Approval of Its Critical Access Hospital Accreditation Program”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HYMPAVZI 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; HYMPAVZI”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZIIHERA 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; ZIIHERA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INJECTAFER 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 drug product.

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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EMRELIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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; EMRELIS”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENFLONSIA 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; ENFLONSIA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYLOY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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; VYLOY”

This proposed notice acknowledges the receipt of an application from Joint Commission for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. It also provides the public with the opportunity to submit comments on the applicant's request.

Original title: “Medicare and Medicaid Programs; Application From Joint Commission (JC) for Continued CMS-Approval of Its Home Health Agency (HHA) Accreditation Program”

The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies

Original title: “Government-Owned Inventions; Availability for Licensing”

The Department of Health and Human Services (HHS) is issuing this notice to revise its Statement of Organization, Functions, and Delegations of Authority for the Office of the Secretary (OS). This reorganization removes the Office of the Chief Information Officer (OCIO) from the organizational description for the Office of the Assistant Secretary for Administration (ASA), and establishes the OCIO as a stand-alone organization that reports directly to the Secretary and Deputy Secretary. These cha

Original title: “Statement of Organization, Functions, and Delegations of Authority”

With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.

Original title: “Rare Disease Leaders Call for Regulatory Clarity as FDA Balances Urgency With Rigor”

As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.

Original title: “Pharma's Reluctance To Serve Europe To Dodge MFN Drug Pricing Is Chilling”

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 KRESLADI (marnetegragene autotemcel), app

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel)”

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

Original title: “Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies”

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Advisory Board on Radiation and Worker Health (ABRWH).

Original title: “Advisory Board on Radiation and Worker Health; Notice of Charter Renewal”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the National Committee on Vital and Health Statistics (NCVHS). The meeting is open to the public.

Original title: “Meeting of the National Committee on Vital and Health Statistics”

Original title: “National Eye Institute; Cancellation of Meeting”