๐‡๐จ๐ฐ ๐ญ๐ก๐ž ๐…๐ƒ๐€’๐ฌ ๐๐ž๐ฐ ๐‚๐จ๐ฆ๐ฆ๐ฎ๐ง๐ข๐œ๐š๐ญ๐ข๐จ๐ง ๐Œ๐ž๐š๐ฌ๐ฎ๐ซ๐ž๐ฌ ๐‚๐š๐ง ๐…๐š๐ฌ๐ญ-๐“๐ซ๐š๐œ๐ค ๐๐ข๐จ๐ฉ๐ก๐š๐ซ๐ฆ๐š๐œ๐ž๐ฎ๐ญ๐ข๐œ๐š๐ฅ ๐ƒ๐ž๐ฏ๐ž๐ฅ๐จ๐ฉ๐ฆ๐ž๐ง๐ญ โ€“ (Biopharma Regulatory Affairs)

Authored by Lital Israeli Yagev

The Food and Drug Administration (FDA) has always been pivotal in drug and biopharmaceutical development. With the enactment of the Prescription Drug User Fee Act (PDUFA) VII for the period 2023-2027, the FDA has introduced innovative measures that promise to revolutionize the way biopharmaceutical developers communicate with the agency, potentially fast-tracking the development process.

One of the main introductions under PDUFA VII is the expansion of the INTERACT meeting program. Originally, this program was designed to offer early advice on various aspects such as toxicology, proof-of-concept, biodistribution study design, Chemistry, Manufacturing, and Controls (more on CMC regulatory affairs) issues, and first-in-human trials, primarily in collaboration with the Center for Biologics Evaluation and Research (CBER). Now, this program has extended its reach to include similar engagements with the Center for Drug Evaluation and Research (CDER). This expansion is a significant boon for developers of complex pharmaceuticals, particularly at stages where clear guideline documents may not be readily available. By engaging with the FDA in these early stages, developers can gain invaluable insights and guidance, smoothing the path for their innovative products and the opportunity for another free consultation with the FDA, as part of the Pre-IND meeting for a later stage.

Adres operates as a regulatory affairs consultancy specializing in regulatory affairs, Medical QA and CMC. Navigating the intricate crossroads of innovation and regulation can be daunting, and securing professional advice is not merely advantageousโ€”it is imperative.
We encourage you to seek assistance without reservation. We are here for you incase you have questions. Come pick our brains!

In addition to the INTERACT meetings, the FDA has introduced a new Type D meeting. This meeting format is designed to accelerate feedback from the agency on a narrow set of issues, limited to two focused topics. The unique aspect of this meeting type is its efficiency and specificity, involving only a few associated questions and the participation of no more than three disciplines within the FDA. What makes Type D meetings particularly appealing is the FDA’s  commitment to providing response to meeting request within 14 days and written response within 50 calendar days. This rapid turnaround  enables developers to receive timely feedback and make quicker decisions in their development process.

These new communication routes under PDUFA VII represent a significant step forward in the FDA’s approach to supporting drug and biopharmaceutical development. By offering more structured and timely interactions, the FDA acknowledges the complexities of modern pharmaceutical development and actively works to facilitate and expedite these processes.


The FDA’s new communication measures under PDUFA VII mark a pivotal shift in the landscape of biopharmaceutical development. By embracing these opportunities, developers can navigate the regulatory process more efficiently, bringing their groundbreaking treatments to the market faster than ever before.

Donโ€™t hesitate to reach out for support. Remember, in this journey, youโ€™re not alone. Feel free to contact us and pick our minds.

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Attention startups in the bio pharma community!

Last week at Adres we hosted our first LinkedIn Live with over 200 participants ๐Ÿ™Œ

It was great to share our knowledge and experience with the bio pharma community and give you the confidence that you are on the right track with your clinical development program.

In this session, we focused on:

Process Validation and the importance of arriving prepared for this critical milestone

When is the right time to start preparing?

Shifting your mindset to understand the โ€˜Processย isย the Productโ€™

Avoiding delays on your critical path

If you werenโ€™t able to join us live, you can stillย watch the recordingย here:

Feel free to Contact us for any questions and consultations, weโ€™ll be happy to assist!

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