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.

view more
Go!

recent posts

Labor Cost Differences: Generic vs Brand Drug Production Explained
Labor Cost Differences: Generic vs Brand Drug Production Explained

Generic drugs cost far less than brand-name drugs not because ingredients are cheaper, but because labor costs are structured differently. Learn how scale, regulation, and global production shape the real cost of your prescriptions.

Published ON: 9 Feb
How to Track Post-Marketing Studies for Drug Safety
How to Track Post-Marketing Studies for Drug Safety

Learn how post-marketing studies track drug safety after approval, using FAERS, Sentinel, and real-world data to catch hidden risks. Understand the systems, challenges, and future of pharmacovigilance.

Published ON: 11 Feb
Team-Based Care: How Multidisciplinary Teams Are Changing Generic Prescribing
Team-Based Care: How Multidisciplinary Teams Are Changing Generic Prescribing

Team-based care transforms how generic drugs are prescribed by bringing together doctors, pharmacists, and nurses to improve safety, adherence, and cost savings - especially for patients with multiple chronic conditions.

Published ON: 18 Feb
Pharmacy Verification Services: How to Check Online Pharmacy Licenses for Safety
Pharmacy Verification Services: How to Check Online Pharmacy Licenses for Safety

Learn how to verify online pharmacy licenses to avoid counterfeit drugs. Step-by-step guide to using state and NABP verification systems for safe medication purchases.

Published ON: 15 Feb
How the FDA Ensures Generic Drug Quality During Manufacturing
How the FDA Ensures Generic Drug Quality During Manufacturing

Discover how the FDA maintains strict quality standards for generic drugs through cGMP regulations, unannounced inspections, and rigorous testing. Learn about the five key control areas, global comparisons, and real-world impact on drug safety and affordability.

Published ON: 4 Feb

categories

archives

tags

online pharmacy side effects health benefits dietary supplement benefits coping strategies alternatives treatment erectile dysfunction medication side effects generic drugs mental health generic medications dietary supplements desloratadine bipolar disorder risks cancer treatment role chemotherapy