Tag: ANDA

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.
wayne Holloway in: Medications 26 December 2025

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with affordable access. It slashed drug costs by 90% for most prescriptions-but loopholes now threaten its success.

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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
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
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 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
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

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