
In the evolving phase of drug development, the establishment of 505(b)(2) new drug application (NDA) process offers mid-sized small molecule developers an efficient way to bring novel drugs to market by utilizing existing literature or research, reducing development time and expense compared to the traditional 505(b)(1) pathway that requires comprehensive original investigations. The success of a 505(b)(2) application depends on a customized development approach that takes into account the unique attributes of the proposed drug product and any modifications made compared to previously approved listed drugs or literature.
At Haleus, we are renowned for our proficiency in regulatory submissions, efficiently tackles complex challenges, ensuring clients’ peace of mind, as demonstrated in a recent study project.
Case Study: Switching Barriers into Potential Prospects
A mid-sized drug company intended to assess a new composition and dosage form for previously licensed non-steroidal anti-inflammatory drugs (NSAID) in terms of both patient compliance and efficacy. This modified formulation was aimed for the US market and was meant to treat cramps of the muscles and stomach pain. The challenges that followed stood in the way of the company’s regulatory process, which required a 505(b)(2) submission:
- Insufficient knowledge of the 505(b)(2) application procedure.
- Intricate standards for data handling.
- Lack of a detailed regulatory strategy.
To determine how to navigate these challenges, the client solicited professional regulatory advice from Haleus.
Step 1: Haleus Cultivating Familiarity and Trust
Our regulatory team initiated a collaborative meeting to understand client’s objectives, timeline constraints, and concerns, with our scientific and regulatory teams providing a comprehensive presentation.
- The advantages, prerequisites, and important distinctions between ANDA, 505(b)(2), and 505(b)(1) submissions.
- A thorough plan with important deadlines and checkpoints.
In this way, the client was provided with a comprehensive understanding of the 505(b)(2) process through a transparent and step-by-step approach.
Step 2: Complete Gap Analysis and Data Evaluation
Our team analyzed the safety, efficacy, and pharmacokinetic profile of an existing NSAID to ensure a strong regulatory submission. We compared the new formulation with other NSAIDs, reviewed clinical trial databases for duplications, and identified gaps requiring further studies, such as pharmacokinetics and comparative safety evaluations. By building bridge studies that adhered to FDA guidelines, we minimised duplication while maintaining compliance.
Step 3: Detailed and Complete Regulatory Planning
Our team created a comprehensive plan for the entire submission process, from IND submission to final NDA submission in eCTD format, including publishing, compiling, and submitting data through the FDA’s electronic portal, incorporating existing data, and evaluating the drug’s medical, scientific, regulatory, and commercial viability. By exploring prospects for market exclusivity and setting the product apart from competitors, Haleus set up the customer for success.
Step 4: FDA Guidance and Engagement in Submission Process
Our proficient regulatory team members and consultants led pre-IND and pre-NDA meetings with the FDA to align client’s approach, gain feedback, and ensure clear understanding of regulatory expectations and effective responses to FDA queries.
Our team meticulously documented the dossier, incorporating literature, prior approval findings, and new data from bridging studies, acting as an extension of the client’s team, ensuring seamless communication and regulatory compliance.
Result oriented submission within accelerated timelines and lower costs
Thanks to Haleus’ expertise helped a client submit their 505(b)(2) application in just one month, reducing development costs and minimizing the need for extensive clinical trials. This collaboration showcases how expert guidance can transform challenges into opportunities, paving the way for regulatory success. We demonstrated how tailored solutions and seamless execution can efficiently bring innovative drugs to market.
Finally, Partnering with Haleus in navigating complex regulatory pathways, ensuring compliance, reducing risks, and accelerating timelines, helping them turn challenges into opportunities.