FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation
- 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
- HPV vax gives herd immunity
- APP2026 comp closes on Fri
- First PFIC drug listed on PBS
- Formula recall
- FIP emergency healthcare module
- Nurse banned for illegal botox
- Dispensary Corner 12 Jan 26
- Pharmacists in the making
- 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
