Author: Casper Mallory

Market Exclusivity Extensions: How Pharma Companies Extend Monopolies Beyond Patents

Market Exclusivity Extensions: How Pharma Companies Extend Monopolies Beyond Patents

Market exclusivity extensions let pharmaceutical companies block generic drugs for years after patents expire. Learn how NCE, orphan, and pediatric exclusivities stack to create 20+ year monopolies - and why it matters for drug prices.

Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them

Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them

FDA deficiency letters delay generic drug approvals by highlighting critical gaps in submissions. Learn the top 5 reasons for these letters-and how to avoid them with better preparation, testing, and communication.

Bempedoic Acid Side Effects: Gout, Tendon Risks, and What You Need to Know

Bempedoic Acid Side Effects: Gout, Tendon Risks, and What You Need to Know

Bempedoic acid helps lower cholesterol for statin-intolerant patients but carries risks like gout, tendon rupture, and elevated liver enzymes. Know the signs, manage the risks, and ask the right questions before starting.

Medication Safety Myths vs. Facts: What Patients Really Need to Know

Medication Safety Myths vs. Facts: What Patients Really Need to Know

Many patients believe dangerous myths about medications-from OTC drugs being harmless to stopping antibiotics early. These myths lead to thousands of preventable hospital visits. Here are the facts that can save your life.

How to Verify Medication Dose Changes and Avoid Miscommunication Errors

How to Verify Medication Dose Changes and Avoid Miscommunication Errors

Learn how to verify medication dose changes and prevent communication errors with step-by-step protocols, real-world examples, and practical tips. Essential for healthcare providers.

Feverfew and Anticoagulants: Bleeding Risk Assessment and Safety Guide

Feverfew and Anticoagulants: Bleeding Risk Assessment and Safety Guide

Feverfew supplements can dangerously increase bleeding risk when combined with blood thinners. Learn real cases, expert advice, and steps to stay safe. Essential info for supplement users on anticoagulants.

OTC to Prescription Switches: Safety Considerations for Consumers

OTC to Prescription Switches: Safety Considerations for Consumers

OTC switches make medications more accessible, but they also increase risks of misuse, interactions, and hidden dangers. Learn how to use over-the-counter drugs safely and avoid common mistakes that lead to serious health problems.

How to Subscribe to FDA Drug Safety Alerts and Updates

How to Subscribe to FDA Drug Safety Alerts and Updates

Learn how to subscribe to free FDA drug safety alerts for recalls, side effects, and label changes. Get timely updates on medications you take - and avoid hidden risks before they affect you.

Pharmacist Recommendations: When to Suggest Authorized Generics

Pharmacist Recommendations: When to Suggest Authorized Generics

Pharmacists should recommend authorized generics when patients have allergies to inactive ingredients, take narrow therapeutic index drugs, or use modified-release formulations. These are identical to brand-name meds but cost significantly less.

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

The first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. This rule was meant to speed up affordable drugs-but loopholes let companies block competition without selling anything.