The Food and Drug Administration (FDA or Agency) has determined that ZANTAC (ranitidine hydrochloride (HCl)) injection, equivalent to (EQ) 25 milligram (mg) base/milliliter (mL), has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviat

Original title: “Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mupirocin nasal ointment, 2%, if all other legal and regulatory requirements are met.

Original title: “Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

Original title: “Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000039) entitled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use." This proposed order, if finalized, will amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemot

Original title: “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use”

The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The statutory authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. T

Original title: “Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate”

EMA welcomes the landmark political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of…, Today marks a historic milestone for European medicines regulation and for patients across the EU. The revamp of the pharmaceutical legislation will enable EMA and the…, The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simp

Original title: “EMA welcomes political agreement on new EU pharmaceutical legislation”

Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.

Original title: “FDA Proposes Expanding Sunscreen Active Ingredient List”

EURORDIS welcomes EU institutions’ final agreement on reforms to the bloc’s General Pharmaceutical Legislation The post EURORDIS welcomes final agreement on the EU Pharma Package  appeared first on EURORDIS-Rare Diseases Europe.

Original title: “EURORDIS welcomes final agreement on the EU Pharma Package ”

This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.

Original title: “Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model”

The Food and Drug Administration (FDA, the Agency, or we) is announcing a request for information from interested parties and the public to share their perspectives with FDA on testosterone replacement therapy for men. The Agency intends to use the information submitted to help inform considerations related to testosterone therapy for men.

Original title: “Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 6672: Mental Health Professionals Workforce Shortage Loan Repayment Act of 2025”

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Conjunctivitis Section ("Draft Guideline"). The Draft Guideline includes updates to the Guideline for infection control in health care personnel, 1998 ("1998 Guideline"), Part E: Epidem

Original title: “Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Conjunctivitis Section”

Ordered to be Reported (Amended) by the Yeas and Nays: 40 - 2.

Original title: “HR 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (p

Original title: “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability”

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

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

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

The second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance report is now published, consolidating data from the EU including…, With ESUAvet, we are not just collecting data - we are building trust, enabling action, and contributing to a healthier future for all. Reliable data support smarter…, Sales data of antimicrobials for food-producing animalsIn 2024, 98% of total sales of antimicrobial VMPs were for food-producing animals. Sales for

Original title: “New data on antimicrobials sales and use in animals in the EU”

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.

Original title: “Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts”

The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.

Original title: “FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies”