Regulatory pipeline
Drug pipeline & approvals
Review approvals, regulatory notices, and agency-driven pipeline updates in the same premium layout used on the homepage.
1683 tracked updates • 19 agencies indexed
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Latest pipeline updates
Showing 200 of 1,683 tracked regulatory updates
Após 30 anos, a Lei de Propriedade Industrial precisa evoluir, afirma presidente da Interfarma
EU Innovation Network (EU IN)
La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de un lote del producto cosmético Suavinex Baby Cologne Memories
Γενόσημα Ιανουαρίου 2026_Τελικές Προτεινόμενες Τιμές
FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost?
Field Safety Notices: 1 May 2026
List of Field Safety Notices for 1 May 2026.
Decision: Medical devices given exceptional use authorisations
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
MHRA approves Linerixibat (Lynavoy) for the treatment of itch due to biliary tract disease
As with all medicines, we will continue to closely monitor the safety and effectiveness of linerixibat as it is used more widely.
Visian® ICL™/TICL™ Online Calculation Software
Between April 13 and 16, 2026, the Visian® ICL™/TICL™ online calculation software may have generated incorrect Implant Orientation Diagram (IOD) printouts used for EVO/EVO+ Toric ICL implantation. The issue affected only the printed diagram and not the lenses themselves.
HydroMARK™ Breast Biopsy Site Marker
Devicor Medical Products, Inc. is initiating a voluntary medical device recall for certain HydroMARK™ Breast Biopsy site markers due to incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. Users should immediately remove from use any devices labeled as 4010-02-15-T4 from lot F12607207D.
Vivo 45 LS
In devices with the affected firmware versions, treatment in volume-controlled ventilation modes (VCV, VCV-SIMV and VCV-MPV) can, under specific trigger conditions, result in delivered tidal volume being reduced significantly below the set value.
Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies
[KOKUSAI]PMDA-ATC Learning videos have been updated
Field Safety Notices: 20 to 24 April 2026
List of Field Safety Notices from 20 to 24 April 2026.
Monthly update to the submissions under review lists
This is a list of certain drug submissions currently under review. The Submissions Under Review List includes the medicinal ingredient(s) and therapeutic area. Downloadable Excel files are included.
Monthly update to the generic submissions under review list
This is a list of certain generic drug submissions currently under review. The Generic Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area. Downloadable Excel files are included.
Recommended use of some nasal decongestant sprays limited to five days by UK regulator
The MHRA has limited the use of nasal decongestant sprays containing xylometazoline and oxymetazoline to a maximum of five days due to side effects of prolonged use.
Decision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse
There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
Notice: Multiple additions to the Prescription Drug List (PDL) [2026-04-30]
Document to announce multiple updates to the Prescription Drug List.
Medline Convenience Kits Containing Select Polycarbonate Colored Syringes
Specific item(s) and lot(s) of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes are recalled, after identifying unapproved design changes to the products outside of the 510(k) cleared by FDA. Customers must discard the affected products, but all remaining products inside of the kit may be used.
Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
Abbott is sharing important information regarding the Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System, Proclaim™ Spinal Cord Stimulation (SCS) and Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation Systems. The purpose of this communication is to remind health care providers that the systems contain a Surgery Mode feature designed to help protect the implanted device from potential interference associated with the use of electrosurgical units (ESUs) during certain surgical proc
“DIAFORM RX”
Guidance: The Innovative Devices Access Pathway (IDAP)
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Public Alert No. 024/2026 – Alert on Counterfeit Augmentin 625mg Tablets (Batch No. AC3N) in Nigeria
Sixth resumed meeting of the open-ended Intergovernmental Working Group (IGWG 6) on the WHO Pandemic Agreement: PABS instrument
FDA-Approved Marijuana Products and Those Subject to State-Issued Licenses Rescheduled; Marijuana Hearing Calendared; Dispensary Applications Accepted
Note to Industry on Requirement for Bioequivalence Study
Interfarma na Imprensa: Interfarma ressalta importância de previsibilidade regulatória após adiamento da Resolução CMED nº 3/2025
Interfarma destaca papel do acesso sustentável à inovação na edição especial do Global Forum 2026
Acompanhe o Summit Propriedade Intelectual na Agenda Pública
Notice of Compliance (NOC) Data Extracts
The data extract is a series of compressed ASCII text files of the Notice of Compliance (NOC) database.
Defining Leadership for Oneself is Key to Becoming a Leader, ACRP 2026 Panelists Say
ABPI celebrates a month of major investment commitments into UK life sciences
Attendees Encouraged to “Act with Courage, Driven by Purpose” as ACRP 2026 Closes
MHRA hires top global tech talent to transform systems behind regulation of medicines and medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is pleased to announce the appointment of Jason Bonander as its new Chief Digital and Technology Officer (CDTO).
La AEMPS informa del cese de comercialización y la retirada del mercado de Deliplus Men Depil bajo la ducha
Prorrogação da entrada em vigor da Resolução CMED nº 3/2025 é positiva, avalia Interfarma
Register of Innovative Drugs
A listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.
MHRA Safety Roundup: April 2026
Summary of the latest safety advice for medicines and medical device users
Good laboratory practice (GLP) for safety tests on chemicals
Keep up to date with the latest information from the UK GLP monitoring authority.
Seven sentenced after MHRA investigation uncovers £1.8m illegal medicines and steroids network
An MHRA-led investigation has exposed a £1.8 million illegal medicines and steroids network, leading to seven men being sentenced.
ANMAT cancela la habilitación de la firma REHUE S.A. y prohíbe la comercialización de sus productos
PMS-BUSULFAN 6mg/mL: impurity could be out of specification
The content of an impurity could be out of specification before the expiry date in the affected lots.
Medline Disposible Manifolds
Specific items and lots of Medline Manifolds are recalled due to presence of particulate within the fluid path of the Manifolds, with the potential to be introduced into blood circulation and become lodged. This carries a risk of serious injury, such as death. Customers have been advised to destroy them.
Ideal Implant Structured Breast Implant
The potential for deflation occurring shortly after implantation due to a minute piece of silicone disrupting the valve seal.
ANMAT suspendió el certificado de buenas prácticas de la firma ELECTRON PLAST S.A. y prohibió la comercialización de productos de terceros con destino a tránsito interjurisdiccional
Ανακοίνωση σχετικά με την Ευρωπαϊκή Βάση Δεδομένων Ι/Π- EUDAMED
EMA launches new advisory group on vaccine confidence
EMA has set up a new advisory group on vaccine confidence, which will advise the Agency on issues related to vaccine hesitancy and help guide its actions to increase science…, "Vaccine hesitancy is a growing global threat to public health. When public trust declines, infectious diseases can reemerge, putting lives at risk. EMA has a vital…, The advisory group on vaccine confidence will meet quarterly. It includes academics, representatives of healthcare professionals, medical societies and patie
Aπαγόρευση διάθεσης και διακίνησης των προϊόντων
Eκτέλεση προϋπολογισμού μηνός Μαρτίου 2026
La AEMPS adecúa los formatos de antibióticos para alinearlos con las pautas clínicas habituales y evitar su uso inapropiado
Boletín sobre Cosméticos, Biocidas AEMPS y Productos de Cuidado Personal. Enero-marzo 2026
Across the Codes: Navigating MedTech Compliance Expectations in the Region
CRL Release Update – No litigation war yet, but new Citizen Petition beats the drums
Wegovy and Mounjaro for weight loss not funded
Cook Medical Beacon® Tip Centimeter Sizing Catheter
Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all
Automated Impella® Controller
Abiomed, Inc. has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.
Precautionary recall of antidepressant medication due to manufacturing error
The MHRA has advised healthcare professionals to stop supplying the affected batch of Sertraline 100mg and return all remaining stock to their suppliers.
Clinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
Γενόσημα Μαρτίου 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση
New pilot to support development of ‘breakthrough’ medical devices
EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory…
Ανάκληση των παρτίδων του συνημμένου πίνακα του Ιατροτεχνολογικου προϊόντος, MDD Class IIΙ, 16F Dual—Valved Splittable Sheath Introducer
MHRA delivers its targets to increase access to medicines and reinforce UK position as a global destination for life sciences
The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
Transparency data: MHRA Performance Data
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
Corporate report: MHRA Results and Forecast 2025/26; 2026/27
MHRA achievements and highlights for 2025/26 and key projections for 2026/2027.
Not So Fast: When “RAPID” Isn’t Enough
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Clinical trials for medicines: non-investigational medicinal products
Guidance: Clinical Trials Regulations enforcement provisions
Guidance: Clinical trials for medicines: roles and responsibilities
Guidance: Clinical trials for medicines: Archiving and retention of clinical trial records
Clinical trials for medicines: notifiable trials
Clinical trials for medicines: labelling
Clinical trials for medicines: Good clinical practice inspections
Guidance: Clinical trials for medicines: International Council for Harmonisation (ICH) annotations
Guidance: Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol
Guidance: Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment
Leading the Cut: 4 Organizations Take on Site Training Reduction
Νέα ΣΥΦΑ 1ου Τριμήνου 2026 _ Τιμολόγηση Φαρμακευτικών Προϊόντων
Boletín sobre Productos Sanitarios. Enero-marzo 2026
Launch of clinical trial reforms
Patients in the UK to get access to new treatments faster and still safely under new clinical trial regulations coming into force on 28 April 2026.
ACRP 2026 Panelists Encourage Attendees to “Embrace the Now, Ignite What’s Next”
KOMENTARZ z okazji Światowego Dnia Własności Intelektualnej. prof. Rafał Sikorski, Uniwersytet im. Adama Mickiewicza w Poznaniu
Γενόσημα Φεβρουάριος 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση
La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de la tinta para tatuaje Dynamic Candy Apple Red
Attention aux confusions entre flacons
[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
[ANZEN]PMDA Medical Safety Information: Use of Insulin-Specific Syringe- Incorrect dose may cause serious adverse health effects- posted
[KOKUSAI]Information on PMDA Asia Office updated
“What Got Us Here, Won’t Get Us There,” and Other Insights on the Clinical Research Workforce Shared at ACRP 2026
Suspensión de Servicios
ANMAT facilita la importación de productos necesarios para el desarrollo de estudios clínicos
Behind the Budget: What Sites Really Need to Know Today
Why Site Support Goes Unused in Clinical Trials
Mobility in Clinical Trial Operations with the SIP Mobile App: Practical Gains, New Friction Points, and What to Watch
Cardiometabolic Trials are Exposing a Flaw in the Clinical Research Model: Retention is Engineered Upstream
Bridging Innovation and Reality: Why Human Support Is Essential in Tech-Enabled Clinical Trials
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
H2O: Presence of particulate matter in affected lot
Presence of particulate matter in affected lot.
Polysorb Coated Braided Absorbable Single Stitch Reload For Use With The Endo Stitch And Sils Stitch Suturing Devices
On Jan 22 2026, holes were found in both the breather pouch and the foil. During the investigation into the source of the issue, it was determined that the post seal machine was causing damage to the suture package.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its April 2026 meeting.The committee recommended…, CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below. , CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below…, Positive recommendations on new medicines, Cenrifki INN tolebrutinib Marketing authorisation applicant Sanofi Winthrop Indu
Γενόσημα Ιανουάριος 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση
New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
EMA has recommended granting a marketing authorisation in the European Union (EU) for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome (FCS).FCS is…
La AEMPS informa de un posible error de software en las versiones 1.5 a 1.6 de la aplicación Dexcom One+ iOS
Επικοινωνία σχετικά με την οριστική διακοπή κυκλοφορίας επιλεγμένων σκευασμάτων ινσουλίνης
Results May Vary, But Reporting Shouldn’t: FDA Sends a Not-So-Gentle Reminder on ClinicalTrials.gov Compliance
Field Safety Notices: 13 to 17 April 2026
El presidente del CSSP, Lic. Daniel Quinteros, junto con equipo técnico realiza visita a el Instituto Especializado Hospital El Salvador (IEHES)
La AEMPS informa de un posible error en las versiones 2.9.0 a 2.11.2 de las aplicaciones Dexcom G7 iOS y Dexcom G7 Watch iOS
Harmonyair A-Series Surgical Lighting System
Steris identified through customer complaints that paint from the lighting system's light head may begin to peel or chip over time as a result of routine cleaning procedures. While Steris has not received any reports of paint falling from a lighting system during use, if paint particles were to enter the sterile field or fall onto a patient, this could disrupt the procedure resulting in a procedure delay and/or may present a risk of patient infection. Separately, on a smaller number of lighting
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm
Stryker confirmed that certain lots of Hoffman 3 Universal Pin Chucks contained inhomogeneous coating with out-of-specification coating thickness and color. This nonconformance was discovered via product complaint.
Vectorflow Antegrade Catheterization Product
Teleflex has initiated a voluntary recall for certain lots of the above-mentioned products due to receipt of a supplier-initiated recall of the Merit 16f dual-valved splittable sheath introducer component, which is included in impacted arrow hemodialysis kits and sets. According to the recall notice issued by Merit Medical Systems, Inc.' (Merit), in some cases the sheath introducer may not split as intended due to a design related issue.
EMA business hours over King's Day and Labour Day, 27 April and 1 May
EMA's office is closed for King's Day in the Netherlands on 27 April and for Labour Day on 1 May 2026.Outside of working hours and on public holidays, it is…
Precautionary recall of medication used for pain and inflammation due to incomplete patient information
Specific batches of Napralief 250mg Gastro‑Resistant Tablets are being recalled because important safety and dosage information is missing from both the patient information leaflet and the outer carton.
La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de los cosméticos Blonde Henna y Oil Balance, de la marca Real Earth
4S (κάψουλες) (SIBUTRAMINE, PHENOLPHTALEIN)
Boletín sobre Seguridad de Medicamentos de Uso Humano. Febrero de 2026
BABA BERATAN HERBAL MIXTURE, GENTLE DMP DOMIPA HERBAL MIXTURE, MANISA HERBAL MIXTURE, BITKISEL KARISIMLI EPIMEDYUMLU MACUN, LA PEPA NEGRA, ROYAL HONEY
Webinaires EUDAMED : formation aux modules Acteurs, UDI/Dispositifs et Organismes notifiés/Certificats
Απαγόρευση διάθεσης και διακίνησης των συμπληρωμάτων διατροφής YAVA LABS – FAT BURNER BLUEBERRY και YAVA LABS – FAT BURNER COLA
Agenda for May 2026 Immunisation Advisory Committee (IAC) meeting
What Does DOJ’s New Corporate Enforcement Policy Mean for the FDA- and DEA-Regulated Industry?
Información Electrónica de Prescripción (ePI): Acelerando la Transformación Digital de los Sistemas de Salud en América Latina
La AEMPS informa del lanzamiento de un programa piloto de la EMA para impulsar el desarrollo de productos sanitarios y productos sanitarios in vitro innovadores
La AEMPS informa de la detección de productos sanitarios falsos bajo las marcas GEBRO-Mesoceuticals y VANE-Mesoceuticals en el mercado europeo
Adapter For Head Positioning
Baxter Corporation is recalling the product listed due to the potential that the adapter for head positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the upper back section H V U on Baxter operating tables.
Variax 2 Locking Screw - Non-Sterile
Stryker has confirmed that one lot of Variax® 2 Locking crews was manufactured without the hexalobular feature required for mating with the associated screwdriver.
ALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia
Hypertriglyceridemia, including severe and life-threatening events, has been identified as an adverse reaction associated with ALECENSARO. Severe hypertriglyceridemia is considered a medical emergency, as it may lead to acute pancreatitis. Audience Healthcare professionals involved in the treatment of lung cancer, including medical oncologists, thoracic surgeons, surgical oncologists (Quebec), respirologists, oncology nurses, and oncology pharmacists. Key messages Hypertriglyceridemia, including
ANMAT suspende el certificado de BPF y prohíbe la comercialización de productos médicos de la firma RIPEZZI S.R.L.
ANMAT dispuso la suspensión de habilitaciones de la firma BIOGAMMA S.R.L.
Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
As with any medicine, the MHRA will keep the safety and effectiveness of Enflonsia under close review.
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Ανάκληση της Άδειας Χονδρικής πώλησης φαρμάκων για Ανθρώπινη Χρήση στο πρατήριο της εταιρείας ΕΝΟΡΑΣΙΣ ΑΕ
Ανάκληση των παρτίδων 17270129, 17363725, 17385132, του φαρμακευτικού προϊόντος VISIPAQUE INJ.SOL 625 MG(320MG I)/ML BTx1 USB BOTTLE x 100ml
Έντυπα & Διαδικασίες Τμήματος Τιμολόγησης (τελ.τροπ.23-4-2026)
FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 2 of 2)
A Time to Cast Away Meds…
La AEMPS establece los requisitos técnicos para el registro de medicamentos veterinarios no biológicos
ANMAT suspende la habilitación para la distribución interjurisdiccional de medicamentos de la firma GLOBAL PHARMA GROUP S.A.
La AEMPS desmiente el “callo solar” y recuerda la importancia de una exposición solar segura
Boletín del Comité de Medicamentos de Uso Humano. Marzo de 2026
Ενημέρωση για την υποβολή των αιτημάτων τιμολόγησης
Statutory guidance: MHRA fees
FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 1 of 2)
[ANZEN]Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted
Decision: Marketing authorisations Granted in 2026
Reunión del Comité de Medicamentos de Uso Humano de abril de 2026
Precautionary recall of blood pressure medication after manufacturing error
The MHRA has advised pharmacy and healthcare professionals to stop supplying the impacted batch and return all remaining stock to their suppliers.
Decision: Parallel import licences granted in 2026
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19
SUVEXX: The assay is out of specification in the affected lot.
The assay is out of specification in the affected lot.
Max Slim Alpha-GPC + Citicoline: The affected lot contains an undeclared ingredient (caffeine)
The affected lot contains an undeclared ingredient (caffeine).
ACI’s 2nd Annual Summit on GLP-1 Law & Policy
La UE abre consulta pública sobre la propuesta de restricción de las PFAS
[KOKUSAI]A new page for the Regulatory Symposia has been launched.
Agenda for May 2026 Pharmacology and Therapeutics advisory committee (PTAC) meeting
Circular on Implementation of Prior intimation System for Form CT-05 application (for export purpose only) w.e.f 21.04.2026 in pursuance of G.S.R 50(E) dated 21.01.2026
[Circulars] 2026-Apr-20
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HCPChFeLV, for the active immunisation of…
EMA recommends authorisation of first veterinary vaccine using RNA technology
EMA has recommended granting a marketing authorisation in the EU for Nobivac NXT HCPChFeLV, a vaccine for protecting cats against common infectious diseases.The vaccine…
Allergovit 123 Parietaria 100% suspensión inyectable, en su formato de Mantenimiento de 2 viales, concentración B (10.000 UT/ml)
Ανάκληση παρτίδων των καθετήρων μπαλονιού κρυοκατάλυσης POLARx και POLARx FIT, των κατευθυνόμενων θηκαρίων POLARSHEATH
La AEMPS informa de retrasos en el restablecimiento del suministro de Tenormin 0,5 mg/ml solución inyectable
Κύρια σημεία συνεδρίασης της Επιτροπής Αξιολόγησης Κινδύνου Φαρμακοεπαγρύπνησης (PRAC), 7 – 10 Απριλίου 2026
Promotional material: National AI Commission: Ask Me Anything
Dispositifs médicaux et dispositifs médicaux de diagnostic in vitro : un arbre décisionnel pour aider les acteurs concernés par l’article 10bis des règlements européens
Ανάκληση του συμπληρώματος διατροφής MemoVigor2, δισκία, με αρ. παρτίδας Ι015 και ημερομηνία λήξης 02/2027
Enough Will They-Won’t They! FDA Pushes for Permanent Rare Pediatric Disease PRVs
Tulipe et le Snitem signent un partenariat pour renforcer la mobilisation des industries de santé dans l’aide médicale humanitaire
Ingenia and Achieva Systems
Philips has become aware through the MRE software system developer Resoundant about an issue affecting MRE stiffness measurements when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. Specifically, the reconstruction voxel size settings in the default MRE scan protocol are too small, which can potentially lead to inaccurate liver stiffness measurements (lower values). Philips has identified a software issue affecting Philips Vue Motion v12.2
Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Clinical trials for medicines: guidance on quality and risk proportionality
Δήλωση Αποθεμάτων Φαρμάκων Ανθρώπινης Χρήσης
Flash VIG-news - Vaccin Ixchiq contre le chikungunya : rappel des recommandations
FDA Looks East—Here’s What Industry Needs to Know
Transparency data: MHRA annual accountability review minutes
Recherche & industrie : le rêve d’une France souveraine, à l’épreuve des choix
Guidance: RSV Vaccine Factsheet – Information for Patients, Parents and Carers
Bard Dynamic Deca Steerable Diagnostic EP Catheter and Daig Livewire Steerable Diagnostic EP Catheter
Stryker Sustainability Solutions (SSS) has received complaints reporting EP catheter devices with breached sterile barriers on the chevron seal side of the primary Tyvek pouch.
SynchroMed Clinician Programmer Application
Complaint investigations identified a software sequencing issue in the Medtronic A810 SynchroMed Clinician Programmer Application (CP app), specifically affecting flex dosing when programming the SynchroMed 8637 and 8667 pumps. When flex dosing steps are added overlapping and then out of chronological order, the app may fail to reorder them correctly, resulting in infusion steps being delivered at incorrect times. This can lead to missed flex doses, underdosing, or shifts in dose timing, and no
i‑STAT EG7+ Cartridge
Cartridges from the specific lots listed may report higher than expected pCO2 and lower than expected pH results due to a manufacturing issue which may present a pattern suggestive of severe respiratory acidosis. If such results are acted upon without consideration of the patient's overall clinical presentation, this could lead to unnecessary or inappropriate clinical interventions. Use of the cartridges should be discontinued for pH and pCO2.
Actualizaciones del Código Alimentario Argentino
Ανάκληση της παρτίδας EM1425 του καλλυντικού προϊόντος NEPTUNE AFTER SHAVE
Ανάκληση της παρτίδας 333570 του συμπληρώματος διατροφής HEALTHAID HAEMOVIT, Liquid Gold Blackcurrant taste
How to seize the growing opportunities of AI and technology ahead
By Dame Jennifer Dixon
Reunión del Comité de Medicamentos Veterinarios de abril de 2026
FDA Launches READI-Home Innovation Challenge: Opportunities—and Tensions—for Home-Use Device Developers
M/s Mehta API Pvt. Ltd. – Agomelatine (IH) and 19 items
[International Certificates] 2026-04-15 00:00:00.0
M/s. BMS Chemie, – Benzbromarone СРand Benzbromarone IÐ
[International Certificates] 2026-04-15 00:00:00.0
Managing Financial Risk at the Site Level: Practical Strategies for Underfunded Studies
Updated Register of Certificates of Supplementary Protection and Applications
Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection Regulations.