EMA Enhances PRIME Scheme to Accelerate Medicine Development
The European Medicines Agency (EMA) has launched three new features for its PRIME scheme, designed to accelerate the development of medicines targeting unmet medical needs. These tools aim to streamline scientific dialogue and provide developers with faster answers and better preparation for marketing authorisation applications.
Market expansion of sweet potato roots from Korea
The Animal and Plant Health Inspection Service (APHIS) has published a notice regarding the expansion of market access for sweet potato roots originating from Korea. This action allows for the importation of sweet potatoes from Korea into the United States.
Sweet Potato Import Risk Management Document from Korea
The Animal and Plant Health Inspection Service (APHIS) has published a risk management document detailing requirements for importing sweet potatoes from Korea. This document outlines the necessary measures to mitigate potential pest and disease risks associated with these imports.
Pest Risk Assessment: Sweet Potato Roots from Korea
The Animal and Plant Health Inspection Service (APHIS) has published a pest risk assessment concerning the importation of sweet potato roots from Korea into the United States. This assessment evaluates potential risks associated with the commodity.
REACH CLP Highlights from March RAC and SEAC meetings
ECHA has published highlights from the March meetings of the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). These highlights cover discussions and opinions related to REACH and CLP regulations, including a draft opinion on a PFAS restriction proposal.
Mama Grande Tortilla Factory Recalls Gorditas for Undeclared Wheat and Soy
Mama Grande Tortilla Factory is recalling Gorditas de Azucar and Doraditas de Azucar due to undeclared wheat and soy. The recall impacts products distributed in Texas between February 2, 2026, and March 5, 2026. No illnesses have been reported.
Health Canada Task Force on Pharmaceutical Access and Innovation
Health Canada and Innovation, Science and Economic Development Canada have launched a joint Pharmaceutical and Life Sciences Sector Task Force. The task force will support access to pharmaceuticals and identify solutions to drive innovation and growth in the Canadian life sciences sector.
FDA Early Alert: Handy Solutions Heating Pad Issue
The FDA issued an Early Alert regarding a potentially high-risk issue with Handy Solutions Neck & Shoulders Heating Pads manufactured by Navajo Manufacturing Company. The device can overheat and cause burns or property damage, with four serious injuries reported.
HSA Warns Public About Products with Banned or Potent Medicinal Ingredients
The Health Sciences Authority (HSA) in Singapore has issued a warning regarding four products found to contain banned or potent medicinal ingredients, including steroids and sibutramine. Three consumers experienced serious adverse effects after consuming these products. HSA is working to remove listings and investigate sellers.
CMS Seeks Public Comment on Information Collection
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information from the public under the Paperwork Reduction Act. The notice provides a 60-day comment period for interested parties to submit feedback on the proposed information collection.
CMS Medicare Data Application for Performance Measurement Comment Period
The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on its intention to collect information related to Medicare data applications for performance measurement. This notice is part of the Paperwork Reduction Act process, requiring a 60-day public comment period.
FDA Indexes New Drug for Ornamental Finfish Parasites
The FDA has added Prazi-Med, a praziquantel powder for immersion, to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. This drug treats internal and external parasites in ornamental finfish, providing a faster and less expensive pathway to market for such products.
WHO Report: Child Mortality Slows, 4.9 Million Die Before Five
A new UN report indicates that while child deaths have fallen globally since 2000, the pace of reduction has slowed significantly since 2015. In 2024, 4.9 million children died before their fifth birthday, with preventable causes like malnutrition and infectious diseases being major factors. The report highlights disparities in healthcare access, particularly in sub-Saharan Africa and conflict-affected regions.
Atropine Eye Drops: Medication Error Risk in Children Under 3
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice regarding the risk of medication errors with atropine eye drops in children under 3 years old. The notice highlights specific risks and provides recommendations to prevent these errors.
FDA Early Alert: Insulet Omnipod 5 Pods May Not Deliver Insulin
The FDA has issued an Early Alert regarding Insulet Omnipod 5 Pods that may have a tear in internal tubing, potentially leading to under-delivery of insulin and high blood glucose levels. Insulet has issued a voluntary correction recommending affected pods not be used, with 18 serious injuries reported.
OSHA Notice: UL LLC Application for Recognition Expansion
OSHA has announced that UL LLC has applied to expand its recognition as a Nationally Recognized Testing Laboratory (NRTL). The agency is presenting its preliminary finding to grant this application. Comments on the application are due by April 2, 2026.
NIOSH Seeks Public Comment on Draft Lewisite IDLH Value Profile
The CDC's NIOSH is requesting public comment on a draft Immediately Dangerous to Life or Health (IDLH) Value Profile document for the chemical lewisite. The comment period closes on May 18, 2026.
CDC Draft IDLH Value Profile for Lewisite
The CDC has released a draft Immediately Dangerous to Life or Health (IDLH) value profile for Lewisite. This document is open for public comment and provides scientific information to inform occupational safety standards.
ANSM Safety Alert: B. Braun Infusion Sets and Mentor Tissue Expanders
The ANSM has issued a safety alert regarding specific lots of B. Braun infusion sets and Mentor tissue expanders. A lot recall has been implemented by the manufacturer, B. Braun Medical Inc., and Mentor. Affected users have been notified.
ANSM Safety Alert for Soltive SuperPulsed Laser Systems
The French ANSM has issued a safety alert (R2607992) regarding Soltive SuperPulsed laser systems, following a security action initiated by Olympus. Affected users have been notified directly by the manufacturer.
FDA Draft Guidance on New Approach Methodologies in Drug Development
The FDA has issued draft guidance for industry on the use of New Approach Methodologies (NAMs) in drug development. The guidance provides a validation framework and recommendations to improve human relevance and reduce animal testing, encouraging NAMs in regulatory submissions.
SC Board of Pharmacy: Revised Vaccine Administration Protocol
The South Carolina Board of Pharmacy has revised its protocol for vaccine administration by pharmacists, effective September 17, 2025. The primary change allows pharmacists, interns, and technicians to administer FDA-approved COVID-19 vaccines without a practitioner's order, following specific professional recommendations.
Idaho Pharmacy Licensure Renewal Cycle and Fee Updates
The Idaho Board of Pharmacy is updating its licensure renewal cycles and fees effective July 1, 2025. Pharmacist licenses will now expire on the licensee's birthday, with renewals shifting to a two-year cycle, and associated fees will double for biennial renewals.
Idaho Pharmacy Board: Ivermectin OTC Update
The Idaho Board of Pharmacy has issued an update regarding the over-the-counter availability of Ivermectin. This notice clarifies regulatory standing following legislative changes, referencing Senate Bill 1211.
Idaho Board of Pharmacy: Expedited Temporary Licensure Pathway for Rite Aid Closure
The Idaho Board of Pharmacy has established an expedited temporary licensure pathway due to the closure of Rite Aid pharmacies. This pathway aims to ensure continuity of pharmaceutical services for patients affected by the closures.
Idaho Board of Pharmacy Grants Medication Authority to Naturopaths
The Idaho Board of Pharmacy has announced that naturopaths are now granted medication authority. This change expands the scope of practice for licensed naturopathic physicians in Idaho, allowing them to prescribe certain medications.
CMS Seeks Public Comment on Information Collection Activities
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information, specifically regarding the State-based Exchange Annual Reporting Tool (SMART). This notice is part of the Paperwork Reduction Act process, allowing for public input on the necessity and utility of the proposed information collection.
CMS Seeks Public Comment on Information Collection Proposals
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information from the public, as required by the Paperwork Reduction Act. This notice provides an opportunity for stakeholders to comment on proposed information collections, including revisions to existing ones.
FDA Draft Guidance on Alternatives to Animal Testing in Drug Development
The FDA has issued draft guidance to assist drug developers in validating new approach methodologies (NAMs) as alternatives to animal testing in drug development. This guidance supports the FDA's roadmap to reduce animal testing and bring safe, effective drugs to market sooner.
FDA Early Alert: Surgical Stapler Issue Linked to Bleeding, Death
The FDA issued an Early Alert regarding a potentially high-risk issue with Intuitive Surgical's 8mm SureForm 30 Gray Reload surgical staplers. The issue has been linked to incomplete staple lines, causing bleeding and resulting in four serious injuries and one death. Affected customers are advised to immediately stop use and quarantine the product.
MHRA Modernises Medicine Information Delivery
The MHRA has launched a project to modernise how medicines product information is delivered to patients, aiming for greater accessibility and trust. This initiative includes research into the role of patient information leaflets.
CMS Agency Information Collection Activities Proposed for Public Comment
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on proposed information collections under the Paperwork Reduction Act. The comment period is open for 60 days, closing on May 18, 2026.
CMS Seeks Public Comment on Information Collection Activities
The Centers for Medicare & Medicaid Services (CMS) is requesting public comment on its intention to collect information from the public, as required by the Paperwork Reduction Act. This notice provides an opportunity for comment on the necessity, utility, and burden of proposed information collections.
FDA Notice: Preparation for Cosmetics Regulation Meeting and Request for Comments
The FDA is requesting public comments to prepare for the twentieth International Cooperation on Cosmetics Regulation (ICCR-20) annual meeting. The input will help inform the agency's participation in discussions on cosmetics regulation. Comments are due by May 18, 2026.
OTC Monograph Drug Facility Fee Rates for FY 2026
The FDA has published the Over-the-Counter (OTC) Monograph Drug Facility (MDF) fee rates for fiscal year 2026. These fees are authorized by the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II) and support FDA's OTC monograph drug activities.
FDA Advisory Committee Renewal: Obstetrics, Reproductive and Urologic Drugs
The Food and Drug Administration (FDA) has announced the renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years. The committee's charter will now be in effect until March 23, 2028, continuing its role in advising on drug safety and effectiveness.
FDA: Gluten Labeling and Cross-Contact Comment Period Extension
The Food and Drug Administration (FDA) has extended the public comment period for its request for information regarding gluten labeling and preventing cross-contact in packaged foods. The original notice was published on January 22, 2026, and the comment period is now extended to April 22, 2026.
FDA Guidance on Topical Drug Product Characterization for ANDAs
The FDA has issued a final guidance document for industry on the physicochemical and structural characterization of topical drug products submitted in abbreviated new drug applications (ANDAs). This guidance provides recommendations to assist applicants in identifying dosage forms and describing critical performance properties to support bioequivalence demonstrations for generic topical products.
FDA Determination: Methergine Injection Not Withdrawn for Safety or Effectiveness
The FDA has determined that Methergine (methylergonovine maleate) injection was not withdrawn from sale for safety or effectiveness reasons. This determination allows the FDA to approve abbreviated new drug applications (ANDAs) for generic versions of this product, provided other requirements are met.
NIGMS Notice of Partially Closed Meetings
The National Institutes of Health (NIH) has issued a notice regarding upcoming partially closed meetings of the National Advisory General Medical Sciences Council. The meetings are scheduled for May 21, 2026, and September 10, 2026, and will include both open sessions for program discussions and closed sessions for grant application reviews.
Center for Scientific Review Notice of Closed Meetings
The National Institutes of Health (NIH) has published a notice announcing upcoming closed meetings for various review committees. These meetings are scheduled for April 2026 and will involve the review and evaluation of grant applications.
Center for Scientific Review Amended Meeting Notice
The National Institutes of Health (NIH) has issued an amended notice regarding a meeting of the Clinical Management in General Care Settings Study Section. The amendment changes the Scientific Review Officer (SRO) for the meeting, which is closed to the public.
OMB Review Request for Hazardous Waste Worker Training Data Collection
The National Institutes of Health (NIH) is requesting public comment on a proposed data collection project related to its Hazardous Waste Worker Training Program. This notice is part of the process for submitting the collection to the Office of Management and Budget (OMB) for review and approval.
Center for Scientific Review; Amended Notice of Meeting
The National Institutes of Health (NIH) has amended a notice regarding a meeting of the HIV Comorbidities and Clinical Studies Study Section. The meeting, originally scheduled for two days, has been changed to a single day on March 27, 2026. The meeting remains closed to the public.
National Institute of Diabetes and Digestive and Kidney Diseases: Amended Meeting Notice
The National Institutes of Health (NIH) has issued an amended notice regarding a meeting for the Board of Scientific Counselors, National Institute of Diabetes and Digestive and Kidney Diseases (DKBSC). The meeting dates have been rescheduled from March 30-31, 2026, to June 10-11, 2026.
DEA: Xylazine Involved in 6,096 Overdose Deaths in 2023
The DEA issued a public safety alert stating that xylazine was involved in 6,096 overdose deaths in 2023, making it the fourth most common drug in such fatalities. The alert indicates that all 50 states have reported the presence of xylazine in the illicit drug supply.
CDC Request for Comment on Draft IDLH Value Document for Lewisite
The CDC's National Institute for Occupational Safety and Health (NIOSH) is requesting public comment on a draft Immediately Dangerous to Life or Health (IDLH) Value Profile document for the chemical lewisite. The comment period closes on May 18, 2026.
MHRA: Baxter Onkotrone Injection Defective Patient Information Leaflets
The MHRA has issued a Class 4 Medicines Defect Notification regarding Baxter Healthcare Corporation's Onkotrone Injection. Certain batches contain Patient Information Leaflets (PILs) with outdated contraception duration information. Healthcare professionals are advised to inform female patients of the updated requirement.
MHRA-NICE Joint Process for Faster Medicine Approvals
The MHRA and NICE have launched a new joint pathway and an improved Integrated Scientific Advice service to streamline medicine approval processes in England. This aims to bring new medicines to patients up to six months sooner by synchronizing licensing and value assessment decisions.
DEA Announces Multiple Drug Enforcement Actions and Arrests
The DEA has announced multiple drug enforcement actions and arrests across various field divisions, including significant seizures of illicit funds and convictions for drug trafficking and money laundering. These actions highlight ongoing efforts to combat transnational criminal organizations and dismantle drug distribution networks.
HRSA - Delta States Rural Development Grant Program Information Collection Revision
The Health Resources and Services Administration (HRSA) is seeking public comment on a proposed revision to the Delta States Rural Development Network Grant Program's information collection request. This revision aims to modify how race and ethnicity measures are displayed in the data collection platform.
HRSA Countermeasures Injury Compensation Program Information Collection Revision
The Health Resources and Services Administration (HRSA) has submitted a revised Information Collection Request (ICR) for the Countermeasures Injury Compensation Program (CICP) to the Office of Management and Budget (OMB) for approval. This notice requests public comments on the revisions, which aim to improve efficiency and data quality.
FDA Final Guidance on Topical Drug Product Characterization for ANDAs
The FDA has issued final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). This guidance assists applicants in identifying generic topical products and supporting bioequivalence demonstrations. It finalizes the draft guidance issued in October 2022.
AMA Applauds Bill Exempting Physicians from H-1B Visa Fee
The American Medical Association (AMA) is applauding the introduction of bipartisan legislation that would exempt physicians and other health care professionals from a $100,000 filing fee on new H-1B visa petitions. This action aims to alleviate costs for hiring medical professionals and address physician shortages.
FDA Warning Letter to Citra100mg for Unapproved Opioid Sales
The FDA issued a warning letter to Citra100mg for unlawfully selling unapproved and misbranded opioid drugs, including tramadol, to U.S. consumers over the internet. The agency cited violations of the Federal Food, Drug, and Cosmetic Act and highlighted the public health risks associated with unapproved opioids.
FDA Warning Letter to Flowchem Pharma Private Limited
The FDA issued a warning letter to Flowchem Pharma Private Limited following an inspection that revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). The letter details issues with equipment cleaning and maintenance, which could compromise API quality and safety.
FDA Warning Letter to Patcos Cosmetics for Adulterated Drugs
The FDA issued a warning letter to Patcos Cosmetics Pvt. Ltd. for insanitary conditions and violations of Current Good Manufacturing Practice (CGMP) at their drug manufacturing facility. The letter details specific violations observed during an inspection and deems the company's response inadequate.
FDA Warning Letter to Trangs Group USA Incorporated
The FDA issued a warning letter to Trangs Group USA Incorporated for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, including specific frozen bao products. The FDA may take further action if the violations are not addressed.
FDA Warning Letter to Prilla.com for Unapproved Nicotine Products
The FDA issued a warning letter to prilla.com/us on March 6, 2026, for marketing new nicotine pouch products without the required premarket authorization. The agency determined that products like VITO Watermelon 6mg and VITO Mango Fusion 6mg are adulterated and misbranded under the FD&C Act.
FDA Warning Letter to OraLabs Inc. Regarding Drug Manufacturing
The FDA issued a warning letter to OraLabs Inc. for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to conduct necessary laboratory testing for drug products, leading to adulterated drugs. The FDA requires a comprehensive remediation plan and testing of retain samples.
FDA - Better Being Co. Solaray StressMag Product Information
The FDA has posted information regarding Better Being Co.'s Solaray StressMag product, which claims to support mood and relaxation. This filing appears to be a notification or informational submission related to a specific product. No new regulations or enforcement actions are detailed.
FDA - Harmony Foods LLC. Meijer Fiber Gummies Submission
Harmony Foods LLC. has submitted information regarding their Meijer Fiber Gummies 72ct product to the Food and Drug Administration (FDA). This submission is part of the agency's regulatory process for food products.
FDA Submission for Harmony Foods Magnesium Citrate Gummies
The FDA has received a submission from Harmony Foods LLC regarding their Meijer Magnesium Citrate Gummies. This notice pertains to a product submission and does not contain new regulatory requirements or guidance.
FDA Filing: New Chapter Women's 50+ Multivitamin
The FDA has received a filing from New Chapter regarding their Women's 50+ Multivitamin. This filing pertains to a product supporting immune function, cellular energy, and antioxidants for healthy aging. No specific compliance actions or deadlines are indicated in this notice.
Harmony Foods B12 Gummies Docket Information
The FDA has posted docket information for Harmony Foods LLC concerning their Free & Pure Zero Sugar B12 Gummies. This notice provides access to supporting documentation related to the product, as filed with the agency.
FDA Submission: Bio Minerals N.V. Biosil Daily Beauty Protein Vanilla
The FDA has received a submission from Bio Minerals N.V. regarding their product, Biosil Daily Beauty Protein Vanilla. This submission is part of the agency's regulatory process for new product information.
FDA - Blueroot Health Submission on Respiratory and Immune Function
The FDA has received a submission from Blueroot Health regarding their product, Vital Nutrients, Aller-C, which is intended to support healthy respiratory and immune function. This submission is part of the public record available on Regulations.gov.
FDA CDRH Variance Approval Letter for Photon GFX
The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Photon GFX. This notice indicates a specific approval for a medical device variance, though no further details or documents are available for review.
FDA Complaint Document
The FDA has posted a complaint document to the Regs.gov portal on March 17, 2026. The document is available for public viewing and download via the provided link.
FDA Variance Application from Alpha-Omega Services
The FDA has received a variance application from Alpha-Omega Services, Inc. The application pertains to medical device regulations. Further details are available via the provided URL.
FDA Complaint Document
The FDA has posted a complaint document related to FDA-2026-H-2311-0001. The document is available for review on the Regs.gov platform. No further details on the nature of the complaint or its implications are provided.
FDA GRAS Notice 1288 Amendment for Steviol Glycosides
The FDA has posted an amendment to GRAS Notice 1288 concerning enzyme-modified steviol glycosides. This notice is from the manufacturer and is part of the Generally Recognized As Safe (GRAS) notification process.
FDA CDER Response Letter to Hyman, Phelps & McNamara
The FDA's Center for Drug Evaluation and Research (CDER) has posted a response letter addressed to the law firm Hyman, Phelps & McNamara, P.C. The document was made available on March 17, 2025, through the Regs.gov portal. No other details regarding the content of the response are provided.
FDA Document on GreenBio Nutrients Joint Health Capsules
The FDA has posted a document related to GreenBio Nutrients Inc.'s ILEXPOWER and JointAlive Capsules. The document is available for review on the Regs.gov platform. No specific regulatory action or compliance requirement is detailed in the provided information.
FDA Complaint Consultation
The FDA has posted a complaint for public comment, with the comment period closing on March 17, 2026. This action allows stakeholders to provide input on the complaint's content.
FDA Closes Comment Period for Blueroot Health Nutrient Submission
The FDA has closed the public comment period for a nutrient submission from Blueroot Health concerning their B6 + B Complex product. The submission was related to energy metabolism support. No further action is required from the public at this time.
FDA - Swanson Health Products Menopause Support
The FDA has posted a document related to Swanson Health Products' Menopause Support supplement. The document, identified as FDA-2025-S-0024-1968, is available for review on the Regs.gov platform. No specific regulatory action or compliance requirement is detailed in the provided information.
Harmony Foods Multivitamin Gummies - FDA Docket
The FDA has opened Docket FDA-2025-S-0024 concerning Harmony Foods Multivitamin Gummies. An attachment from Harmony Foods LLC provides details on their Meijer Wellness Women's Multivitamin Gummies.
FDA Complaint Document
The FDA has posted a complaint document to the Regs.gov portal. The document, authored by CTP, is available for review and download. No specific details regarding the nature of the complaint or its implications are provided in the metadata.
FDA Complaint Document
The FDA has posted a complaint document related to FDA-2026-H-2575-0001. The document was made available on March 17, 2026, and is authored by CTP.
FDA Acknowledgment Letter to Lusonix Group
The FDA has posted an acknowledgment letter sent to Lusonix Group regarding a submission. The letter, authored by CDRH, confirms receipt of materials but provides no further details on the nature of the submission or any regulatory actions.
Luxsonix Group Variance Approval Letter
The FDA has issued a variance approval letter to Luxsonix Group. This notice pertains to a specific variance granted by the Center for Devices and Radiological Health (CDRH).
FDA Consultation on i-Health Inc. Culturelle Gummies
The FDA has opened a comment period regarding i-Health Inc.'s Culturelle Women's Probiotic + Multivitamin Gummies. This consultation seeks public input on the product, with specific details available via the provided link.
FDA: L-Theanine Powder Supports Relaxation Claim
The FDA has received a submission regarding L-Theanine Powder, specifically from Threshold Enterprises (Source Naturals), for its product that claims to support relaxation and ease everyday stress. This notice indicates a submission for a dietary supplement claim.
FDA - Vitanica BreastBlend Claim Review
The FDA has received a submission regarding Vitanica's BreastBlend product, which claims to support healthy breast tissue. This notice indicates the FDA is aware of the product and its claims, but no specific regulatory action or enforcement is detailed in the provided information.