Tag: ANDA application

Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Review

Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Review
wayne Holloway in: Medications 24 December 2025

GDUFA laws let the FDA collect fees from generic drug makers to speed up approval of affordable medications. Since 2012, review times have dropped from years to months, helping millions access low-cost drugs faster.

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Dry Eye Management from Medications: Lubricants and Humidifiers
Dry Eye Management from Medications: Lubricants and Humidifiers

Learn how to manage dry eye symptoms with lubricants and humidifiers. Discover which eye drops work best, why humidifiers help, and how to combine treatments for real relief.

Published ON: 10 Jan
Chronic Cough Workup: How to Diagnose GERD, Asthma, and Postnasal Drip
Chronic Cough Workup: How to Diagnose GERD, Asthma, and Postnasal Drip

Chronic cough lasting over 8 weeks is usually caused by GERD, asthma, or postnasal drip. Learn the step-by-step diagnostic workup that works - without unnecessary scans or meds - and how to find relief in weeks, not years.

Published ON: 13 Jan
Statin Interactions That Increase Myopathy Risk: What You Need to Know
Statin Interactions That Increase Myopathy Risk: What You Need to Know

Statins reduce heart attack risk but can cause muscle damage when combined with certain drugs. Learn which statins and medications raise myopathy risk, how to spot symptoms, and safer alternatives.

Published ON: 11 Jan
SSRIs with NSAIDs: How This Common Medication Combo Raises GI Bleeding Risk and What to Do
SSRIs with NSAIDs: How This Common Medication Combo Raises GI Bleeding Risk and What to Do

Combining SSRIs and NSAIDs significantly raises the risk of dangerous gastrointestinal bleeding. Learn why this common drug combo is risky, who’s most vulnerable, and what steps to take to stay safe - including safer pain relief options and when to use protective medication.

Published ON: 4 Jan
Shortage mitigation strategies: what health systems are doing to fight drug shortages
Shortage mitigation strategies: what health systems are doing to fight drug shortages

Health systems are using AI, regional sharing, alternative formulations, and care redesign to combat drug shortages. Here’s what’s working-and what’s still failing-in 2025.

Published ON: 3 Jan

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