This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of Bayesian methods in clinical trials.
- Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam
- Final Report FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications
- Human Drug Imports
- Importing Liquid Cough and Cold Medicine from India
- Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
- FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
- FDA Approves First Over-the-Counter Naloxone Nasal Spray
- FDA/Center for Research on Complex Generics (CRCG) Workshop on Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products – 11/19/2025
- A Robust Multistep Digestion Method for Microplastics Detection in Human Tissue by MicroRaman Analysis
- FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 – 01/21/2026
- 1095: Does Routine Magnesium Supplementation in ICU Patients Reduce Tachyarrhythmias?
- HL7 V2 to FHIR
- Nutrition
- 1092: Should hot or cold compresses be used to treat extravasation?
- Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
- Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
- Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
- 1088: All My Antibiotics: The CAP Guideline Drama
- Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
- Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
- Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
- Spring & Mulberry Issues Voluntary Recall of Mint Leaf Date Sweetened Chocolate Bar Due to Possible Salmonella Contamination
- Nurse banned for illegal botox
- Dispensary Corner 12 Jan 26
- Pharmacists in the making
- HPV vax gives herd immunity
- APP2026 comp closes on Fri
- First PFIC drug listed on PBS
- Formula recall
- FIP emergency healthcare module
- PD for Mon 12 Jan 2026
- vVARDIS Founders Present Drill-Free Early Cavity Treatment and Unveil Global Cavity Awareness Campaign at the 2026 J.P. Morgan Healthcare Conference
- HealthTrust Workforce Solutions Receives Esteemed Modern Healthcare Best in Business Award
- HealthTrust Performance Group Receives Two Esteemed Modern Healthcare Best in Business Awards
- Macy’s to close Oklahoma fulfillment center
- AtriCure Reports Preliminary Results for Fourth Quarter and Full Year 2025, Provides Financial Outlook for 2026
- EndoQuest to Bring AI-Powered Vision and Precision to Endoluminal Robotic Surgery with NVIDIA IGX Thor
- Vizient Clinical Data Base recognized as one of Modern Healthcare’s Best in Business
- Productivity speeds up to fastest clip in two years: BLS
- Walmart, Wing to scale drone delivery operations to 270 stores
- Americhem to Spotlight New Materials Addressing PFAS, Traceability, and Performance Demands in Medical Devices at Pharmapack and MD&M West 2026
- Vizient and AdventHealth Expand Agreement for Advanced Data and Digital Services
- Astoriom Appoints Will Edwards as Chief Executive Officer
- Aptar’s Eye Care Solutions Designed to Improve Dosing Precision, Including Newest Technology, Beat the Blink™
- UnitedHealth ‘aggressively’ gaming Medicare Advantage, Senate investigation finds
- Hyland Brings Enterprise Content Management to Pathology with Tribun
- Food Business Karison Foods & Snacks Inc Recalls ‘PANJIRI’, ‘ALSI PINNI’, ‘PUNJABI PINNI’, ‘BESAN LADDOO’, and ‘NO SUGAR ADDED BESAN LADDOO’ Due to Undeclared Milk Allergen
- CIO Podcast – Episode 106: State Health Departments with Scott Martin
- Healthcare private equity dealmaking boosted by IT in 2025: report
- From Slides to Simulations: Rethinking Security Training in Healthcare
- Service Dog Saves Veteran From PTSD and Dangerous Heart Condition
- January 11 to January 17 Horoscope Forecast: Your Zodiac Sign’s Week
- This Fake Boss Scam Is Fooling Employees—Here’s What to Know
- Cozy Things to Do in Asheville, NC That’ll Make You Fall in Love
- This USPS Reschedule Delivery Text Is a Scam—Here’s How To Spot It
- 11-Year-Old’s Charity for Scoliosis Donates 870 Dolls With Back Braces: ‘So They Don’t Ever Feel Alone’
- Tax Scam Alert: Fake Consultants Are Draining Bank Accounts
- That Friendly ‘Wrong Number’ Text? It’s A Scam. Here’s Why
- Aldi’s Valentine’s Day Finds Are All Under $20—See What’s New
- Online Shopping Warning: The ‘Out of Stock’ Scam You Need to Know
- Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.
- Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits
- Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
- Gusto Group Inc. Recalls Shrimp Paste (Klong Kone) ‘’454 G. (1 LBS)’ and ‘910 G. (2 LBS)’ because of Possible Health Risk
- Carrot Top Kitchens of Bridgeport (formerly Redding) Issues a Class II Recall of Hummus Containing Undeclared Sesame
- Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
- Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
- Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods
- Consumers Supply Distributing, LLC Recalls Country Vet Biscuits for Dogs Due to Possible Salmonella Health Risk
- Gregory’s Foods Issues Allergy Alert on Undeclared Peanuts in “Bag Full of Cookies” White Chocolate Macadamia Nut Frozen Cookie Dough
