Tag: generic drug fees

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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Spanish-Language Resources on Generic Medications: What Patients Need to Know
Spanish-Language Resources on Generic Medications: What Patients Need to Know

Spanish-language resources on generic medications help patients understand that cheaper pills are just as safe and effective as brand names. Learn where to find trusted tools, what to ask your pharmacist, and why regional language differences matter.

Published ON: 19 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
How to Manage Medication Storage in Shared Living Spaces
How to Manage Medication Storage in Shared Living Spaces

Learn how to safely store medications in shared homes with lockable storage, proper temperature control, labeling, and disposal practices to prevent accidents and ensure effectiveness.

Published ON: 11 Dec
HBV Reactivation: How Biologics and Chemotherapy Trigger Liver Danger - And How to Prevent It
HBV Reactivation: How Biologics and Chemotherapy Trigger Liver Danger - And How to Prevent It

HBV reactivation can strike silently during chemotherapy or biologic therapy, causing liver failure. Learn who's at risk, which drugs trigger it, and how simple screening and antiviral prophylaxis can save lives.

Published ON: 18 Dec
FDA Warning Authority: How the Agency Takes Action Against Non-Compliant Manufacturers
FDA Warning Authority: How the Agency Takes Action Against Non-Compliant Manufacturers

The FDA issues warning letters to manufacturers who violate safety and labeling laws. These letters are the first step in enforcement that can lead to recalls, fines, or criminal charges. Learn how the agency targets non-compliant companies and what you must do to avoid serious consequences.

Published ON: 1 Dec

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