Archive: 2025/11
Prescriber Education Resources: Guides for Doctors on Generics
Doctors need clear, evidence-based guides to confidently prescribe generic medications. Learn how FDA resources help bridge the gap between science and patient trust, reduce costs, and improve adherence.
FDA Facility Inspections: How the Agency Ensures Quality in Manufacturing
FDA facility inspections are a critical part of ensuring medicines and medical devices are made safely. Learn how the agency selects sites, what happens during inspections, common violations, and how manufacturers prepare to pass them.
Pregnancy and Medications: What You Need to Know About Teratogenic Risks and Birth Defects
Learn the real risks of medications during pregnancy, which drugs can cause birth defects, and how to make safe choices-backed by current medical guidelines and expert insights.
PDE5 Inhibitors and Nitrates: What You Must Know About the Life-Threatening Blood Pressure Drop
Combining PDE5 inhibitors like Viagra or Cialis with nitrates can cause a life-threatening drop in blood pressure. Learn why this interaction is dangerous, how long to wait between doses, and what to do if you're at risk.
Primary Sclerosing Cholangitis: What You Need to Know About This Rare Liver Disease
Primary sclerosing cholangitis is a rare, progressive liver disease that damages bile ducts, leading to scarring and liver failure. Learn about symptoms, diagnosis, treatments, and emerging therapies.
Reimbursement and Coding for Biosimilars: How Billing Works Under Medicare Part B
Learn how biosimilars are billed under Medicare Part B, including HCPCS codes, reimbursement rules, the JZ modifier, and why adoption remains low despite cost savings.
Energy Drinks and Stimulant Medications: Blood Pressure and Heart Risks
Energy drinks combined with stimulant medications like Adderall or Ritalin can dangerously raise blood pressure and heart rate, increasing the risk of heart attacks and arrhythmias - especially in teens and young adults.
Insulin Pump Therapy for Type 1 Diabetes: Pros, Cons, and How to Get Started
Insulin pump therapy offers better blood sugar control and flexibility for type 1 diabetes, but comes with technical risks and costs. Learn the pros, cons, and how to get started safely.
180-Day Exclusivity and Authorized Generics: Legal Pitfalls and Market Impact
The 180-day exclusivity rule was meant to reward generic drug makers for challenging patents-but authorized generics let brand-name companies undercut them. Here’s how the law works, why it’s failing, and what’s being done to fix it.
Prescription Label Warnings: What Medication Stickers Really Mean
Prescription label warnings are critical safety tools-but most people don’t understand them. Learn what black box warnings, color-coded stickers, and common phrases like 'take with food' really mean-and how to avoid dangerous mistakes.
Pediatric Exclusivity: How the FDA Extends Market Protection for Drugs
Pediatric exclusivity gives drugmakers six extra months of market protection after completing FDA-requested pediatric studies. It doesn't extend patents but blocks generic approval, making it a powerful tool in drug lifecycle management.
Proton Pump Inhibitors and Osteoporosis: What You Need to Know About Fracture Risk
Long-term use of proton pump inhibitors may increase fracture risk, especially in older adults and those with other bone health risks. Learn how PPIs affect bone density, who’s most at risk, and what steps to take to protect yourself.