To further accelerate access to affordable, high-quality generic medicines, the U.S. Food and Drug Administration (FDA) provide Product-Specific Guidance's (PSGs) that outline the agency’s current expectations for demonstrating therapeutic equivalence to reference listed drugs (RLDs).

These guidance's are essential tools for the generic pharmaceutical industry, helping developers identify appropriate methodologies for product development and the types of evidence required to support Abbreviated New Drug Application (ANDA) approval.

Why Product-Specific Guidance's Matter

PSGs provide transparency on FDA’s regulatory expectations, ensuring:

• Clearer pathways for ANDA submissions.
• Improved resource allocation for pharmaceutical companies.
• Reduced uncertainty in development programs.
• Faster access for patients to affordable alternatives.

By keeping policies, regulations, and scientific standards aligned with advances in equivalence science, FDA ensures that generic drug development continues to evolve alongside innovation.

Accessing the Product-Specific Guidance's Database

The FDA maintains a searchable PSG database featuring:

• Text search by active ingredient, Reference Listed Drug (RLD), or Reference Standard (RS) application number.
• Filtered search results for more precise navigation.
• Export options in Excel, CSV, or PDF format.
• Paginated search results for efficient access.

This database provides applicants with user-friendly tools to quickly identify guidance relevant to their products.

Updates & Revisions

The FDA routinely publishes and revises PSGs, incorporating scientific advances and stakeholder input. All draft guidance is open for public comments before finalization, giving industry stakeholders a chance to contribute to regulatory clarity.

Planned updates are listed on the Upcoming Product-Specific Guidance's for Generic Drug Product Development page, ensuring developers are aware of forthcoming changes.

PSG Teleconferences and Meetings

FDA provides opportunities for industry feedback through structured interactions:

• PSG Teleconferences: Available when a new or revised PSG is published after an applicant has already initiated an in vivo bioequivalence study. These discussions clarify the potential impact of new requirements on ongoing programs.
• Pre-submission or Post-submission PSG Meetings: Offered following teleconference feedback to further refine development strategies.

These processes, reinforced under GDUFA III enhancements, provide developers with greater regulatory support and reduce risks of costly delays.

Conclusion

FDA’s Product-Specific Guidance's serve as vital resources for the pharmaceutical industry, offering transparency, predictability, and efficiency in generic drug development. By aligning scientific expectations with evolving methodologies, these guidance's support both regulatory compliance and public health goals by ensuring timely access to affordable medicines.

At Maven Regulatory Solutions, we specialize in supporting pharmaceutical companies through every stage of ANDA development, from interpreting PSG requirements to preparing robust regulatory submissions. Our expertise helps you stay compliant, avoid costly pitfalls, and accelerate your path to the market.