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Pharmaceutical industry news

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🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised dr...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Expedited Investigational New Drug Pilot Program; Request for Information

The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guid...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal RegisterOriginal source
🌍Industryrss.globenewswire.comTier 3 · Secondary coverage

ARS Pharmaceuticals Provides Commercial and Financial Updates

ARS PharmaceuticalsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: METOPROLOL TARTRATE

Official structured record identifier: e1c99d45-8f42-46b1-b770-14d0eb2b300a.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Tamsulosin Hydrochloride

Official structured record identifier: b30e2bde-b20e-4899-a100-f44170d8165b.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Ergocalciferol

Official structured record identifier: a80436e0-b507-4e7b-9a60-a9d5ddc4a045.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Methoxsalen

Official structured record identifier: a6ec8292-9189-4ebd-862a-e1725eb29eef.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Desogestrel and Ethinyl Estradiol

Official structured record identifier: 78454ebf-f1a3-4ca0-b32e-88c51bc57773.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Nerve Guard Nerve Relief

Official structured record identifier: 6b78f40f-2a7f-4c49-96af-1a95acbf430f.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPES

Official structured record identifier: 54fd0885-0d8c-614d-e063-6394a90acef9.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN

Official structured record identifier: 54fc80b7-8f6c-e2be-e063-6394a90a4b59.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: BAJA BLAST HAND SANITIZING WIPES

Official structured record identifier: 54fc7e91-53f7-70b4-e063-6294a90ac085.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: MOUTAIN DEW HAND SANITIZING WIPES

Official structured record identifier: 54fbbdde-ef7b-0a8b-e063-6294a90ad9e4.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREEN

Official structured record identifier: 51c07375-e81d-8572-e063-6394a90ab5b0.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Nervionoix Pro Neuropathy Fast Acting Cream

Official structured record identifier: 23abdf62-03a8-4aaa-8e29-0e2585b5ade7.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: BUPRENORPHINE HYDROCHLORIDE

Official structured record identifier: 99237.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.

Official structured record identifier: 99137.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: CHLORTHALIDONE

Official structured record identifier: 99136.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: FOCALIN

Official structured record identifier: 99121.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: ALYACEN 1/35

Official structured record identifier: 99101.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: HEALTH-TEC TOPICAL ANESTHETIC

Official structured record identifier: 99076.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: ARIPIPRAZOLE

Official structured record identifier: 99046.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

Official structured record identifier: 99014.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.

Official structured record identifier: 99000.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Official structured record identifier: 99080.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Official structured record identifier: 99041.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Modu

Official structured record identifier: 99023.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline

Official structured record identifier: 98994.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lea

Official structured record identifier: 98990.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

Official structured record identifier: 98951.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Official structured record identifier: 98946.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Official structured record identifier: 98854.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JAC

Official structured record identifier: 98793.

openFDA Device RecallsOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Study protocol and statistical analysis plan for a randomized controlled trial evaluating the safety and feasibility of the recombinant human platelet-derived growth factor B (rhPDGF-BB)-enhanced collagen plug for complex perianal fistula healing

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Effects of silicone-based formulations on laser-induced microscopic lesions: results from a randomized trial using an in vivo human wound healing model.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Artificial intelligence-guided analysis of the tumor microenvironment predicts response to pembrolizumab in rare tumors.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Emerging treatments for Sjögren's disease: promising drugs on the horizon.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Critical Comments by the European Medicines Agency on Patient-Reported Outcomes in Regulatory Submissions (2020-2023).

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Machine learning algorithms to predict spray dried protein/peptide formulations.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Online vs In-Person Care for Atopic Dermatitis: A Randomized Clinical Trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Impact of oliceridine versus sufentanil on postoperative nausea and vomiting in patients undergoing thyroid surgery: a prospective, double-blind, randomized controlled trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Novel uveal melanoma patient-derived cell line and organoid models show increased treatment resistance compared with commercially available cell lines.

Europe PMCOriginal source
🌍Researchdoi.orgTier 1 · Research record

Anesthesia Strategy and Clinical Outcomes in Ruptured Aortic Aneurysm Repair: Insights from EVAR and TEVAR

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Multi-target Mechanism of Action of Curcumin in Rheumatoid Arthritis and Clinical Application

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Role of tumor markers and cytokines in the pathogenesis of lung cancer

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Prominent crosstalks between perineural invasion and immunosuppressive tumor microenvironment in pancreatic ductal adenocarcinoma

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Radiation-induced cardiotoxicity in lung cancer: Current landscape and future directions

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Letter to the Editor: Yin Yang 1 in inflammatory memory and progression susceptibility in <i>Helicobacter pylori</i> –associated gastric cancer

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

MYO-INOSITOL AND D-CHIRO-INOSITOL IN POLYCYSTIC OVARY SYNDROME: MECHANISMS OF ACTION, CLINICAL EFFECTIVENESS, SAFETY, AND CURRENT LIMITATIONS: A NARRATIVE REVIEW

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Effect of Minimizing Light Exposure with Digital Visualization on Macular Function After Cataract Surgery in Patients with AMD: A Randomized Controlled Trial

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Clinical Evaluation of a Combined Deep Learning–Reconstructed Readout-Segmented Echo-Planar Imaging and Water-Excitation Spectral Fat-Saturation Protocol for Breast Diffusion-Weighted Imaging at 3T Breast MRI

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Promoting Physical Activity and Reducing Sedentary Behavior in Adults with Type 2 Diabetes: Study Protocol of the DIA/01 Randomized Trial

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Drug repurposing of sophoridine for sepsis-induced organ injury: from in-depth analysis of a single agent to a multi-target therapeutic paradigm

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Bridging the theory-practice gap in laboratory medicine: development and application of a standardized case library for fostering clinical reasoning in postgraduate training

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Гіперімуноглобулінемія Е як причина тяжкого хронічного інфекційного ураження шкіри: клінічний випадок

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Дезлоратадин у сучасній системі пероральної доставки ліків: вартий вибір для належного лікування алергічних захворювань

CrossrefOriginal source