Tag: GDUFA III

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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FDA List of Authorized Generics: Where to Find and How to Use It
FDA List of Authorized Generics: Where to Find and How to Use It

Find the FDA's official list of authorized generics-drugs made by brand companies but sold without the brand name. Learn where to access it, how to interpret it, and why it's not always easy to buy these lower-cost options.

Published ON: 1 Dec
Lithium Carbonate Generics: What You Need to Know About Serum Levels
Lithium Carbonate Generics: What You Need to Know About Serum Levels

Lithium carbonate generics require strict serum level monitoring due to their narrow therapeutic index. Learn how brand switches, dosing, age, and kidney function affect safety and effectiveness in bipolar disorder treatment.

Published ON: 12 Dec
Antihistamines: First-Generation vs. Second-Generation Compared
Antihistamines: First-Generation vs. Second-Generation Compared

First-generation antihistamines like Benadryl work fast but cause drowsiness. Second-generation options like Zyrtec and Claritin are non-sedating and better for daily use. Learn which is right for your allergies.

Published ON: 3 Dec
NSAIDs and Peptic Ulcer Disease: Understanding the Real Risk of Gastrointestinal Bleeding
NSAIDs and Peptic Ulcer Disease: Understanding the Real Risk of Gastrointestinal Bleeding

NSAIDs like ibuprofen and naproxen are common pain relievers, but they can cause serious stomach bleeding, especially in older adults or those with risk factors. Learn who’s most at risk, how to protect yourself, and what alternatives exist.

Published ON: 2 Dec
How Manufacturers Fix Quality Problems: A Practical Guide to Corrective Actions
How Manufacturers Fix Quality Problems: A Practical Guide to Corrective Actions

Manufacturers fix quality problems by finding root causes, not just symptoms. Learn how CAPA systems, root cause analysis, and verification steps reduce defects, ensure compliance, and prevent recurrence in regulated industries.

Published ON: 5 Dec

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