PFAS Restriction SEAC Draft Opinion Consultation
ECHA's Committee for Socio-Economic Analysis (SEAC) has agreed its draft opinion on the universal restriction proposal for all per- and polyfluoroalkyl substances (PFAS). ECHA's scientific committees support EU-wide PFAS restriction with targeted derogations and controls to address risks to people and the environment. A 60-day public consultation on the draft SEAC opinion runs from 26 March to 25 May 2026.
CMS Hemp-Derived Products Beneficiary Engagement Incentive
CMS announced a new Substance Access Beneficiary Engagement Incentive (BEI) allowing participating Accountable Care Organizations in the ACO REACH and Enhancing Oncology Models to offer eligible hemp-derived products valued at up to $500 per year per beneficiary. Five ACOs have submitted implementation plans for CMS review, with approved participants able to begin offering the incentive starting April 1, 2026.
Phenytoin Sodium Capsules and Chewable Tablets Shortage Notice
Health Canada issued a notice advising that phenytoin sodium capsules and chewable tablets are in short supply until early May 2026. BGP Pharma's Dilantin products and AA Pharma's capsules are constrained, with Taro's oral suspension unable to compensate. Health Canada is coordinating with provincial and territorial governments and stakeholders to manage the shortage.
VIMALKA Trademark - Pharmaceutical Oncology Preparations
USPTO filed trademark application TM99192483 for VIMALKA on May 19, 2025, covering pharmaceutical preparations and products for oncology diseases and disorders under Nice Class 005. The application is classified as Intent-to-Use, indicating the applicant plans to use the mark in commerce.
DELKARMI Trademark Application - Oncology Pharmaceuticals
USPTO received trademark application TM99192498 for DELKARMI, filed May 19, 2025, for pharmaceutical preparations for use in oncology diseases and disorders under Class 005. The application is filed under Intent-to-Use provisions with a stated deadline of March 31, 2026.
Nelkarmi Pharmaceutical Trademark - Oncology
USPTO received trademark application TM99192492 for 'NELKARMI' covering pharmaceutical preparations for oncology diseases and disorders on May 19, 2025. The application was filed under Intent-to-Use provisions with a deadline of March 31, 2026 for the Statement of Use.
DERMOLECULE intent-to-use trademark filed for skincare
DERMOLECULE intent-to-use trademark filed for skincare
Aloe Jack Trademark Application - Class 005
The USPTO received a new Intent-to-Use trademark application (TM99226264) for 'ALOE JACK' in Class 005 covering personal lubricants and medicated body care preparations containing aloe as an active ingredient. The application was filed on June 10, 2025. This filing does not create any compliance obligations for third parties.
Bioharmony trademark renewal Class 005 nutritional supplements
The USPTO renewed trademark registration TM99281541 for BIOHARMONY covering dietary supplements, mineral food supplements, and nutritional supplements. The renewal was processed on March 31, 2026. This is a routine trademark maintenance action with no new obligations for the trademark holder.
Dr. Mariem Health and Wellness Trademark Application
The USPTO received Trademark Application TM99243544 from Dr. Mariem Health and Wellness on June 19, 2025, filed under Intent-to-Use basis. The application covers medicated cosmetics, vitamin supplements, calcium supplements, dietary supplements, and nutritional supplements under Class 005. No compliance obligations are imposed on third parties.
Bryndall Trademark Renewal - Nutritional Supplements
USPTO renewed Bryndall trademark registration TM99255655 covering nutritional supplements. The registration covers probiotic compositions, herbal supplements, vitamin and mineral supplements, dietary supplements, and related products for humans and animals. Trademark protection extended through this renewal.
Sage One Trademark Renewal - Beverages and Dietary Supplements
The USPTO renewed trademark registration TM99257949 for SAGE ONE, extending registration protection through March 31, 2026. The mark covers non-alcoholic beverages including energy drinks, flavored waters, and iced tea, as well as dietary supplements, nutritional supplements, and related products.
TORESSENCE Trademark Application - Intent to Use
The USPTO has published Intent to Use trademark application TM99241954 for TORESSENCE, filed on June 18, 2025. The application covers dietary and nutritional supplements, non-medicated anti-aging serum, cosmetics, and hair care preparations in Class 005. This publication initiates the opposition period during which third parties may challenge the mark.
RETORQ1 Intent to Use Trademark for Supplements and Cosmetics
USPTO received an Intent to Use trademark application for RETORQ1 (TM99242010) filed June 19, 2025. The application covers dietary supplements, nutritional supplements for menopause, non-medicated anti-aging serum, cosmetics, and hair care preparations.
AVEENO Clear + Soothe Trademark Application
The USPTO received an intent-to-use trademark application (TM99254469) for AVEENO CLEAR + SOOTHE filed by Johnson & Johnson Consumer Inc. on June 26, 2025. The application covers International Class 005 goods including acne treatment preparations, medicated acne cleansers, and non-medicated skin care preparations. This is a standard trademark filing with no immediate regulatory implications for other parties.
TÜV SÜD Product Services Voluntary NRTL Termination
OSHA announced the voluntary termination of TÜV SÜD Product Services GmbH's (TUVPSG) recognition as a Nationally Recognized Testing Laboratory (NRTL), effective March 5, 2026. TUVPSG notified OSHA on May 22, 2025, that it would not seek renewal of its recognition expiring March 5, 2026, and transferred existing certifications to TÜV SÜD America, Inc.
Total Knee Replacement Tibial Insert Recall - Exatech Optetrak Logic
ANSM issued a safety alert (R2608390) regarding a lot recall for tibial inserts used in the Optetrak Logic total knee replacement system, manufactured by Exatech Inc. The recall affects hospital pharmacies and surgical centers using these devices. Healthcare facilities must identify and remove the affected lot from inventory.
Recall of Milestone Vacuum Bags - Burn Hazard
ANSM registered recall action R2607842 for Milestone vacuum bags manufactured by Microm Microtech. The recall was initiated due to burn hazard identified in affected products distributed to medical biology laboratories. Users have received notification letters with instructions for returning the recalled items.
Mitomycine Substipharm 20 mg Filter Update for Injection Administration
ANSM issued an updated safety notice for Mitomycine Substipharm 20 mg, permanently including a Millex HV filter (0.45 μm / PVDF) with reconstitution vials. The agency clarified that filtration remains mandatory for intravenous, intra-arterial, and intra-serous administration but is no longer required for intravesical administration. Healthcare professionals in urology, oncology, and related specialties should update their administration protocols accordingly.
Ortho Vision Max Immuno-Hematology Device Safety Alert
ANSM issued a safety information notice (Ref. R2608831) regarding a safety action by QuidelOrtho for Ortho Vision Max and Ortho Vision automated immuno-hematology analyzers. Medical analysis laboratories using these devices have received direct correspondence from the manufacturer about the safety measure. Users with questions should contact QuidelOrtho directly.
PETMEDS Intent-to-Use Trademark Application
PetMed Express filed an intent-to-use trademark application (TM99007390) with USPTO covering online and retail store services for pet supplies, veterinary pharmacy services, pet medications, and nutritional products. The application also covers non-medicated pet care products including shampoos, ear cleaners, grooming preparations, and pet food/treats.
Kobuk Therapeutics trademark application for pharmaceutical preparations
The USPTO received trademark application TM99107436 for 'KOBUK THERAPEUTICS' filed by Kobuk Therapeutics on March 27, 2025. The application covers pharmaceutical preparations and medicines in Nice Class 5 for the treatment of viral, metabolic, cardiovascular, oncological, neurological, and other disease categories. This is an Intent-to-Use application, indicating the applicant plans to use the mark in commerce.
ONCOSPAN Trademark Application for Oncology Research Products
USPTO received trademark application TM99112500 for 'ONCOSPAN' filed March 31, 2025, by a single applicant seeking protection for biological preparations, cell line-derived reference standards, and custom manufacturing services for oncology research products. The application covers goods in International Class 5 including nucleic acid reference standards, FFPE samples, and custom manufactured biological products for clinical diagnostics.
Oncopure trademark, custom biological products, oncology applications
USPTO received trademark application TM99112549 from Oncopure for the ONCOPURE mark in International Class 5 (pharmaceuticals/biologics). The application covers custom biological products for oncology applications including reference standards, nucleic acids, and FFPE samples for research and clinical testing purposes. Filing date is March 31, 2025, with intent-to-use basis and a published abstract date of March 31, 2026.
MEDTIDE Trademark Application
USPTO received an Intent to Use trademark application (TM99057317) for MEDTIDE filed by an unidentified applicant on March 31, 2026. The application covers International Class 005, encompassing pharmaceutical preparations, biopharmaceuticals, diagnostic preparations, chemical compounds for pharmaceutical manufacturing, and medical/therapeutic treatments. No compliance obligations arise from this filing; it represents a standard trademark registration record.
NCHS Research Data Center Forms
CDC's National Center for Health Statistics (NCHS) Research Data Center issued a notice regarding required forms for data access requests. The notice establishes a compliance deadline of June 1 for form submissions. This routine administrative update affects researchers and institutions seeking to access NCHS restricted-use data files through the Research Data Center.
Ultraview SL Command Module Cardiac Output Defect Recall
Health Canada issued a Type II recall for Spacelabs Healthcare's Ultraview SL™ Command Module (model 91496) after production testing discovered the cardiac output function was intermittently yielding bad or irregular curves. Healthcare providers using this multiparameter module should contact the manufacturer for lot information and assess any affected devices in their facilities.
National Blood Collection and Utilization Survey Information Collection
The CDC published a Federal Register notice extending the public comment period for the proposed National Blood Collection and Utilization Survey (NBCUS). The survey is a biennial data collection effort designed to produce national and regional estimates of blood collections, utilization, and safety. Comments on the proposed information collection are due 30 days from the April 1, 2026 publication date.
Priority Review Voucher Issuance for YUVIWEL Rare Pediatric Disease Product
The FDA announced the issuance of a priority review voucher to Ascendis Pharma Growth Disorders (A/S) for YUVIWEL (navepegritide), approved February 27, 2026. The drug is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This notice fulfills FDA's statutory requirement to publish awards of priority review vouchers under section 529 of the FD&C Act.
Determination That INAPSINE Droperidol Injection Was Not Withdrawn From Sale for Safety
The FDA determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to continue approving ANDAs (abbreviated new drug applications) that refer to this product, which is currently listed in the Orange Book's Discontinued Drug Product List. The drug was originally approved under NDA 016796 held by Akorn, Inc.
Petition to Remove Three Solvents from Color Additive Regulations
The FDA announced receipt of a color additive petition from the International Association of Color Manufacturers (IACM) requesting removal of three solvents from 21 CFR Part 73. The petition targets methylene chloride, trichloroethylene, and ethylene dichloride, citing permanent abandonment of these uses in color additive preparation. The FDA is seeking public comments through June 1, 2026.
Acceptable Market Name Change for Certain Rockfish Species
The FDA issued a notice requesting data and information to support an evidence-based determination on potential updates to the acceptable market name for 18 Sebastes rockfish species. This consultation invites stakeholders to submit comments and supporting data on the proposed market name change by May 1, 2026.
ONC Health IT Organization and Authority Structure Updates
HHS published a Federal Register Notice on April 1, 2026, reorganizing ONC (Office of the National Coordinator for Health Information Technology) by reversing the management title of Assistant Secretary for Technology Policy and restoring ONC as a singularly titled office. The roles of the HHS Chief Technology Officer, Chief AI Officer, and Chief Data Officer will no longer be part of ONC, and the organizational structure is consolidated into three offices.
Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals
The DEA published a notice that Royal Emerald Pharmaceuticals applied to register as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370) at its facility in Desert Hot Springs, California. The company proposes to provide cannabis botanical raw material and active pharmaceutical ingredients (API) to DEA-registered researchers and manufacturers. Public comments on the application are due June 1, 2026.
Controlled Substance Importer Application: Fisher Clinical Services
The Drug Enforcement Administration published a notice that Fisher Clinical Services, Inc. applied to be registered as an importer of a Schedule I controlled substance (3,4-Methylenedioxymethamphetamine, Drug Code 7405). The company plans to use the substance for clinical trials only. Registered manufacturers and applicants may submit comments or objections on or before May 1, 2026.
Controlled Substance Importer Application - Fisher Clinical Services
The DEA published a notice that Fisher Clinical Services, Inc. has applied to be registered as an importer of controlled substances. The application covers 3,4-Methylenedioxy-methamphetamine (MDMA, Schedule I, Drug Code 7405) for clinical trials only. The public comment period closes May 1, 2026.
Importer of Controlled Substances Application: Research Triangle Institute
The DEA published notice that Research Triangle Institute applied to be registered as an importer of Schedule I controlled substances, including cathinone derivatives and synthetic stimulants. The application covers basic class(es) of controlled substances listed in the Federal Register. Interested parties may submit comments or objections, or request a hearing on the application.
Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC
The DEA published a notice that Pharmaron Manufacturing Services (US) LLC applied on February 10, 2026 to be registered as a bulk manufacturer of Schedule II controlled substances (Oxycodone, Thebaine, Oxymorphone, and Noroxymorphone) at its facility in Coventry, Rhode Island. The company plans to produce material for clinical trials only. The public has until June 1, 2026 to submit comments or objections to the application.
Sterling Wisconsin LLC, controlled substances importer application
The Drug Enforcement Administration published a notice that Sterling Wisconsin, LLC applied to be registered as an importer of controlled substances (Drug Code 7431 - 5-Methoxy-N,N-dimethyltryptamine, Schedule I). The company plans to import this substance as bulk Active Pharmaceutical Ingredient for internal research, clinical investigational studies, and analytical purposes. Comments on the application are due May 1, 2026.
Indivior Manufacturing LLC Controlled Substances Importer Application
The Drug Enforcement Administration published notice that Indivior Manufacturing LLC (Raleigh, NC) applied to be registered as an importer of Thebaine (drug code 9333, Schedule II controlled substance). The company plans to import the controlled substance for research, clinical trials, analytical purposes, and manufacturing process development. The public comment period closes May 1, 2026.
HOWARU probiotic ingredient trademark application
The USPTO received a trademark application (TM98867137) from DuPont for the HOWARU probiotic ingredient mark under Intent-to-Use basis. The application covers goods including microbial cultures, dietetic foods for medical use, and infant formula. The deadline to demonstrate commercial use is March 31, 2026.
ADPTV Biosource Labs Trademark Application
USPTO received an Intent to Use trademark application TM98566010 from ADPTV Biosource Labs for dietary and nutritional supplements. The application was filed on May 23, 2024, with a stated intent to use date of March 31, 2026. This is a standard trademark registration proceeding in Class 005 covering pharmaceutical and dietary supplement products.
Vascudyne Trademark Application - Vascular Health Biotechnology
Vascudyne, a vascular health biotechnology company, filed Intent-to-Use trademark application TM98449022 with the USPTO on March 14, 2024. The application covers biotechnologically engineered tissue products including cells, tissue cell sheets, biological tissue grafts, and vascular grafts for medical purposes.
ZONNIC Nicotine Replacement Therapy Trademark Application
The USPTO received trademark application TM98935361 for ZONNIC covering pharmaceutical preparations for nicotine replacement therapy and smoking cessation products. The application was filed on January 3, 2025, under Intent to Use provisions, covering goods including tablets, lozenges, patches, gums, sprays, and pouches containing nicotine for medical purposes.
Medici Intent to Use Trademark - Cancer Treatments
The USPTO received a trademark application for "MEDICI" (Serial No. TM98956738) filed by Medici Therapeutics on January 13, 2025. The application covers pharmaceutical preparations for the treatment of cancer, immune system disorders, and related conditions under an Intent-to-Use basis.
Cerevance trademark TM98830357, pharmaceutical research, neurological treatments
Cerevance trademark TM98830357, pharmaceutical research, neurological treatments
Warning Letter to buydeltas.com for Unlawful Nicotine Pouch Sales
The FDA Center for Tobacco Products issued a warning letter to buydeltas.com on March 27, 2026, for selling unauthorized nicotine pouch products (ZYN Nicotine Pouches - Cucumber Lime Slim 6.5MG and Red Fruits Slim 9MG) without required premarket authorization. The products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the Federal Food, Drug, and Cosmetic Act. The company must immediately cease selling all unauthorized tobacco products.
Henan Lvyuan Pharmaceutical Co. Ltd. - CGMP Violations Warning Letter
The FDA Center for Veterinary Medicine issued Warning Letter 320-26-55 to Henan Lvyuan Pharmaceutical Co. Ltd., a Chinese manufacturer of active pharmaceutical ingredients (APIs) for veterinary and human drug compounding. The inspection from September 22-26, 2025 revealed significant CGMP violations including inadequate facility maintenance with extensive corrosion and water leaks that could contaminate APIs and compromise drug quality. The company must respond within 15 business days with corrective actions or face regulatory action including detention of products at U.S. borders.
Contract Testing Laboratory CGMP Violations - Microbiological Testing & Consulting LLC
FDA issued Warning Letter 320-26-53 to Microbiological Testing & Consulting, LLC (FEI 3003875820) on March 16, 2026, citing significant CGMP violations found during a September 8-16, 2025 inspection of their contract testing laboratory in Alsip, IL. The agency identified failures in laboratory controls, inadequate documentation practices, and lack of appropriate media qualification for microbiological testing of drug products under 21 CFR parts 210 and 211.
Exclusive Patent License for PEDF Peptides and Retinal Degeneration Treatment
The National Eye Institute, part of the NIH, has published a notice of its intent to grant an Exclusive Patent License to Perpetual Biosciences, Inc. (New York, NY) covering PEDF (Pigment Epithelium-Derived Factor) peptides for treating retinal degeneration. The license would cover multiple patent applications and issued patents across US, Australia, Canada, European, and Japanese jurisdictions. The public comment period closes on April 16, 2026.
NCI Genomic Data Commons Data Submission Request Form
NCI published a 30-day notice seeking public comments on the NCI Genomic Data Commons (GDC) Data Submission Request Form (OMB Control No. 0925-0752). The form is used by investigators to request submission of cancer genomic data into the GDC for data sharing purposes. Comments are due by May 1, 2026. This extends a prior 60-day notice published February 2, 2026, on which no comments were received.
FDA refuses TRADIPITANT Capsules approval, hearing denied
FDA refuses TRADIPITANT Capsules approval, hearing denied
Center for Tobacco Products Enforcement Complaint
The FDA Center for Tobacco Products filed an enforcement complaint on March 31, 2026, under docket FDA-2026-H-3142. The complaint addresses alleged violations of tobacco product regulations. The respondent must respond to the specific allegations contained in the filed complaint.
Tobacco Product Enforcement Complaint
The FDA Center for Tobacco Products (CTP) filed a complaint on March 31, 2026, docketed as FDA-2026-H-3146. The document initiates an enforcement action against a regulated entity regarding tobacco product compliance. The specific allegations and parties involved are contained in the PDF attachment available through Regulations.gov.
Research Data Center Data Security Forms - Proposed Information Collection
The Centers for Disease Control and Prevention published a notice inviting public comment on a proposed information collection titled 'Research Data Center Data Security Forms for Access to Confidential Data.' The National Center for Health Statistics plans to collect information to fulfill data security requirements when providing access to restricted-use microdata for evidence building purposes. Comments are due by June 1, 2026.
FDA Identifies Serious Liver Injury Cases and Deaths with Tavneos
FDA issued a Drug Safety Communication alerting healthcare professionals and patients about serious postmarketing cases of drug-induced liver injury (DILI), including fatal outcomes, associated with Tavneos (avacopan). FDA identified 76 cases of DILI with reasonable evidence of causal association, including 8 deaths and 54 hospitalizations; some cases involved vanishing bile duct syndrome (VBDS). Healthcare professionals are now advised to conduct enhanced liver monitoring (every 2 weeks for the first month, then monthly for 5 months) and to discontinue treatment if liver enzymes exceed specified thresholds.
eCTD Format Acceptance and Quality Defect Declaration Requirements for Therapeutic Products
HSA Singapore announced that electronic Common Technical Document (eCTD) format will be officially accepted for therapeutic product regulatory dossier submissions effective 1 April 2026, using SG-HSA eCTD version 1.1. Additionally, applicants must provide an official declaration confirming no known quality defects in CMC dossiers for submissions from 1 June 2026 onward.
Field Safety Notices List
MHRA published its weekly list of Field Safety Notices (FSNs) covering 23-27 March 2026, listing 14 medical device safety notices from manufacturers. Devices affected include cochlear implant batteries, MRI systems, intraocular lenses, mammography systems, surgical staplers, ventilators, and X-ray imaging systems from manufacturers including Advanced Bionics, Canon Medical Systems, Philips, Hologic, and Intuitive Surgical. MHRA publishes these FSNs for information only—healthcare providers who receive notices directly from manufacturers must act on them.
LUXA-D Recall - Foreign Capsule Found in Affected Batch
Jamp Pharma is recalling one batch of LUXA-D 2000 units capsules (Lot S2520177, DIN 02442256) from the Canadian market after a capsule containing a foreign product was found in the affected batch. The recall affects wholesalers at the distribution level. Healthcare providers and patients who have this product should verify their inventory and consult their healthcare provider before discontinuing use.
Auro-Canagliflozin Recall - Incorrect DIN on Blister Cards
Health Canada issued a Type III recall for Auro-Canagliflozin 300mg tablets (DIN 02510375) manufactured by Auro Pharma Inc. due to incorrect Drug Identification Number on blister cards. Affected lots XQ3025001A and XQ3025004A are impacted. The recall applies to wholesalers with a depth limited to wholesale distribution.
Virtual Control Groups to Reduce Animal Testing in Medicines Development
EMA's CHMP has issued a draft qualification opinion for virtual control groups (VCG) to replace concurrent animal control groups in rat dose-range finding studies. The consultation runs from 31 March to 12 May 2026, inviting comments from the scientific community and stakeholders on this new approach methodology (NAM).