Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

Introduction:

PSG meetings are crucial touchpoints between the FDA and ANDA applicants, designed to ensure your bioequivalence (BE) studies align with the latest regulatory requirements. These meetings help streamline the approval process by providing clear guidance on BE study designs, enabling compliance with FDA standards, and reducing potential roadblocks in your generic drug development.

Navigating these complex regulatory interactions can be challenging, but having expert support can make a significant difference in achieving timely approvals.

Partnering with a team experienced in regulatory affairs, like Zenovel, can provide the insights and strategies needed to optimize your BE studies and meet FDA expectations effectively.

Why PSG Meetings Matter for BE Experts?

Product Specific Guidance (PSG) meetings are crucial touchpoints with the FDA that can significantly impact the success of your ANDA submissions. Here’s how to make the most of them:

Tailored Consultations and Strategic Guidance at Every Step:

PSG meetings offer timely advice to refine your BE study designs in response to new or revised FDA guidances. Use these meetings to align your strategy with regulatory expectations.

Your Study Design, FDA’s Flexibility:

Deviating from PSG recommendations? PSG meetings provide the forum to present and validate scientifically justified alternative approaches, keeping your submission on track.

Efficient Resolution of Issues; Solve Problems Before They Happen:

PSG meetings and controlled correspondence are designed to resolve BE study issues efficiently, reducing delays and promoting a smoother approval process.

Strategic Timing of Requests:

Request PSG meetings strategically—pre-submission to address new PSG impacts, and post-submission to refine your approach during the assessment cycle.

Streamlined Communication:

Teleconferences, face-to-face meetings, or written responses—select the format that best suits your needs to maximize the impact of your interactions with the FDA.

Make PSG Meetings a Cornerstone of Your BE Strategy:

Leverage PSG meetings to enhance your ANDA submission’s precision, align with FDA expectations, and accelerate your path to market.

Ready to Engage with the FDA? 

Use PSG meetings under GDUFA III to your advantage. Connect with us to discuss how we can support your BE strategy.

Reference:

https://www.fda.gov/media/165468/download