Category: Pharmacy - Page 3
Tentative Approval and Litigation: Navigating the Path to Generic Drug Market Entry
Tentative approval from the FDA lets generic drug makers prepare for market entry while patents are still active. But missing deadlines or mismanaging litigation can cost millions. Here’s how to navigate the system and avoid costly delays.
Serious Adverse Events: Reporting Procedures for Generic Drugs
Despite identical FDA regulations, serious adverse events from generic drugs are severely underreported. Learn why this gap exists, how to report correctly, and what’s being done to fix it.
How Generic Medications Save Thousands on Healthcare Costs
Generic medications save Americans billions each year by offering the same effectiveness as brand-name drugs at a fraction of the cost. Learn how generics work, how much you can save, and what to ask your doctor or pharmacist.
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
Generic drugs must meet the same safety, strength, quality, and bioequivalence standards as brand-name drugs under FDA oversight. Learn how the ANDA process ensures generics are just as effective-and why complex formulations take longer to approve.
Temperature and Humidity Control for Safe Medication Storage: What You Need to Know
Proper temperature and humidity control for medication storage ensures drugs remain effective and safe. Learn the exact conditions needed, where not to store meds, and how to avoid costly, dangerous mistakes.
State Laws on NTI Substitution: Varying Requirements Across the US
State laws on NTI drug substitution vary widely across the U.S., with 27 states restricting generic swaps for medications like warfarin and levothyroxine due to safety risks. Federal rules allow substitutions, but clinical evidence shows dangerous outcomes when small dose changes occur.
Provider Education: Understanding Biosimilar Differences and Why It Matters
Biosimilars offer major cost savings but are often confused with generics. This guide explains how they differ, why provider education is critical, and how to confidently use them in practice.
Bepotastine and Allergic Reactions to Medications: Can It Help Prevent Them?
Bepotastine relieves eye allergy symptoms but cannot prevent allergic reactions to medications. Learn how it works, when to use it, and what alternatives exist for managing drug-induced eye irritation.
How to Compare Dissolution Profiles and What They Mean for Generic and Brand Drugs
Dissolution profile comparison is the key method regulators use to prove generic drugs work like brand-name versions. Learn how f2 scores, pH testing, and statistical models ensure bioequivalence without human trials.
How Government Controls Generic Drug Prices in the U.S. Today
Government controls generic drug prices in the U.S. through Medicaid rebates, Medicare caps, and now direct negotiation. Learn how these rules affect your out-of-pocket costs and what you can do to save money.