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🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Venlafaxine Hydrochloride

Official structured record identifier: 5a990dbd-f280-4caf-b950-4703ee98b230.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: AVANCE ALOE INCONTINENCE CARE

Official structured record identifier: 558d239e-b0cf-c145-e063-6294a90a8a8b.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Minoxidil Hair Growth Serum

Official structured record identifier: 5588032c-c5f7-6339-e063-6294a90a36e7.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Cyclobenzaprine HCL

Official structured record identifier: 55683c5c-0f86-9a26-e063-6294a90a8e8c.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Antifungal Psoriasis Shampoo.

Official structured record identifier: 5512ac82-e3c5-37e6-e063-6294a90a92d6.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: GUNA-VIRUS

Official structured record identifier: 53e741c4-8897-71f3-e063-6394a90a751d.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Tretinoin

Official structured record identifier: 5304df69-5d29-48f5-8227-80c7a6f12e6d.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Imipramine Hydrochloride

Official structured record identifier: 51d3b181-0d15-4782-a966-feb137972b18.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Kids Tummy Relief

Official structured record identifier: 5103a317-5c4a-ec96-e063-6294a90aad7e.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: BeamBalm ANTIFUNGAL FOOT SOAKING PACK

Official structured record identifier: 50044b55-8553-ca52-e063-6394a90a0e54.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Benzonatate

Official structured record identifier: 434130e1-c29c-4029-92c6-7d0f7a928e68.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: METFORMIN HYDROCHLORIDE ER

Official structured record identifier: 3dca884d-ec44-496f-9eeb-31fd8fa3f574.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: unspecified product

Official structured record identifier: 3be2a420-e570-4000-a37e-ce1638cef6dc.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Ibuprofen

Official structured record identifier: 38ebacc3-378f-483e-babc-76119677e7df.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Azithromycin

Official structured record identifier: 333ffe63-aaeb-4dff-b595-1c11209189a6.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Potassium Chloride

Official structured record identifier: 30527e49-6648-44f3-97b2-9c51783ac003.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Evereden Fluid Silk Mineral Sunscreen PRO SPF50

Official structured record identifier: 2cb7773f-9a05-ad02-e063-6294a90af024.

openFDA Drug LabelsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Official structured record identifier: 99269.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.

Official structured record identifier: 99265.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: PERAMPANEL

Official structured record identifier: 99256.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: METHYLERGONOVINE MALEATE

Official structured record identifier: 99240.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: LACOSAMIDE

Official structured record identifier: 99200.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: POVI-ONE

Official structured record identifier: 99191.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: HYDROXYZINE HYDROCHLORIDE

Official structured record identifier: 99131.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: FENOFIBRATE

Official structured record identifier: 99130.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: CHLORAPREP ONE-STEP

Official structured record identifier: 99114.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: CORLANOR

Official structured record identifier: 99077.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

Official structured record identifier: 99032.

openFDA Drug RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Official structured record identifier: 99084.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A

Official structured record identifier: 99073.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Official structured record identifier: 99064.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

Official structured record identifier: 99063.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ08

Official structured record identifier: 99062.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Official structured record identifier: 99045.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP

Official structured record identifier: 99043.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

Official structured record identifier: 99042.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Official structured record identifier: 99002.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Moni

Official structured record identifier: 98968.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500

Official structured record identifier: 98966.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

Official structured record identifier: 98942.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)

Official structured record identifier: 98918.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Official structured record identifier: 98888.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Official structured record identifier: 98701.

openFDA Device RecallsOriginal source

🇺🇸Jul 1Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: INZONE DETACHMENT SYSTEM, REF: M00345100950

Official structured record identifier: 98630.

openFDA Device RecallsOriginal source

🇨🇦Jul 1Industryir.bauschhealth.comTier 1 · Company source

Michael Goettler Resigns from Bausch Health's Board of Directors

Bausch Health (IR News)Original source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

A Bayesian Optimal Interval Design Considering Efficacy and Toxicity in Early Phase Basket Trials.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Emerging Frontiers in Nanomedicine for Colorectal Cancer: A Review of Therapeutic Advances, Clinical Evidence, and Patented Technologies.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Advancing Cancer Cachexia Drug Development: Leveraging Biomarkers and Functional Endpoints to Optimize Trial Design.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Potential Mediators of Efpeglenatide's Cardiovascular Benefit: An Exploratory Analysis of the AMPLITUDE-O Trial.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Tirzepatide as a multi-organ integrator in metabolic diseases: a review of molecular mechanisms and clinical translation.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Efficacy and Safety of Evinacumab in Japanese Patients with Homozygous Familial Hypercholesterolemia: Long-term Results from an Open-label, Single-arm, Phase 3 Trial.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Methodological innovations to advance substance use disorder research: Proceedings of a NIDA workshop on target trial emulation and translational testing of digital health tools.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Population Pharmacokinetic Modeling Study of Glibenclamide in Chinese Healthy Volunteers.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Impact of Information Leakage in Platform Trials With Survival Endpoints on Type I Error Control.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Drug Interactions of Vebreltinib, a Novel Type I c-Met Inhibitor, Coadministration With Rifampin or Itraconazole in Healthy Participants.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Timing of health technology assessment in the United States: An evaluation of ICER reviews over 8 years.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

"Protected time" for clinical investigators in medical oncology: The persistent gap between expectation and reality.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Rejoinder to Commentaries on "A Perspective on the Appropriate Implementation of ICH E9(R1) Addendum Strategies for Handling Intercurrent Events".

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Aligning approaches to rheumatoid arthritis drug development: a comparison of FDA and EMA guidance.

Europe PMCOriginal source

🇪🇺Jul 1Researcheuropepmc.orgTier 2 · Direct publisher

Benzbromarone as a Novel Candidate for Preventing Alzheimer's Disease: Evidence From Real-World Data Screening and in Vitro Validation.

Europe PMCOriginal source