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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

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Published on: March 17, 2023

Generic drug approval: a US perspective.

B P Nagori¹, V Mathur, S Garg

¹Lachoo Memorial College of Science and Technology (Pharmacy Wing), Jodhpur, Rajasthan, India.

Current Medical Research and Opinion

|January 12, 2011

Summary

This summary is machine-generated.

Generic drugs offer an affordable alternative to brand-name medications. The Hatch-Waxman Act established standardized procedures for generic drug approval in the US, balancing innovator and generic company rights.

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Area of Science:

Pharmaceutical Sciences
Regulatory Affairs
Health Economics

Background:

Generic drugs are identical or bioequivalent to brand-name drugs, providing economic alternatives.
The US regulatory landscape for pharmaceuticals significantly impacts drug accessibility and cost.

Purpose of the Study:

To provide a general overview of the procedures and regulatory aspects of generic drug approval in the United States.
To highlight the key legislative framework governing generic drug market entry.

Main Methods:

A systematic literature search was conducted using keywords related to generic drugs and US regulatory acts.
Literature was filtered to identify relevant information on generic drug approval processes and regulations.

Main Results:

Nineteen applicable literature sources were identified after screening.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) provides standardized procedures for generic drug recognition.

Conclusions:

The Hatch-Waxman Act significantly influences pharmaceutical approval, sales, and distribution through provisions like patent challenges and data exclusivity.
This legislation effectively balances the rights of both brand-name and generic drug manufacturers.
Official resources should be consulted for comprehensive information on generic drug approvals.