Featured Articles
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Successful Submission Of A Complex NDA For A Breakthrough Therapy- Designated Product
6/11/2021
Successfully submitting an NDA is more than just checking the boxes; it requires a foundational regulatory and clinical strategy that can adapt to the challenges and competing priorities of the drug development process and ultimately drive the program forward. To guarantee meeting a recent tight NDA submission timeline, we relied upon our regulatory expertise and clinical trial acumen.
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Rho And Anthera Pharmaceticals’ Collaborative Partnership In Cystic Fibrosis
5/24/2021
By providing quality deliverables, actionable insights, and an exceptional customer experience, Rho developed a collaborative relationship with Anthera Pharmaceuticals. The small feasibility project we started with quickly grew to include global project management for Anthera’s pivotal Sollpura study (SOLUTION), management of additional complex protocols, and regulatory support of their liprotamase development program.
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Inspection & Audit Preparation In Decentralized Trials
4/8/2021
Decentralized clinical trials (DCTs) are expanding the potential sources for collection of clinical trial data. To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. While DCTs have changed the data collection landscape, the core elements of an inspection have stayed the same and Sponsors must ensure these new data capture technologies are fit-for-purpose. This article covers the several areas for consideration to ensure audit readiness from start-up through submission.
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How To Determine The Appropriate Listed Drug For Your 505(b)(2) Product Development Program And NDA
2/8/2021
To obtain approval for a new product via the 505(b)(2) pathway relying upon the Agency’s findings of safety and efficacy for a previously-approved drug, the applicant must explicitly identify at least one “listed drug” for which FDA has made a finding of safety and effectiveness, containing the same active ingredient as the applicant’s new product. This blog discusses how the FDA's Orange Book can assist in this process.
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Rho’s Approach To Overcoming Enrollment Challenges In A CNS Trial
1/7/2021
A mid-sized biotech company running a randomized, doubleblind, placebo controlled (1:1) Phase 3 CNS pain study, with a single treatment administration, had achieved ex-US approval yet faced significant enrollment challenges when a modified version of the study was implemented in the US. With a goal of 300 participants, the rate of enrollment sat at a mere 0.5 subjects a month. The best laid plans weren’t cutting it.
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Protocol Planning And Design For Quality Decentralized Clinical Trials
12/18/2020
Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?
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FDA COVID-19 Treatment Development Update
12/16/2020
We are on the verge of a significant breakthrough in coping with the COVID-19 global pandemic, but it will take time for the vaccines to be available in sufficient quantities for everyone in the US who wants to be vaccinated. In the immediate term, there is still a tremendous need for affordable and accessible non-vaccine therapies to treat COVID-19, as well as for the long term to treat those who remain unvaccinated and/or still contract the virus.
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Nonclinical Considerations For 505(b)(2) Development Programs
12/10/2020
Applicants planning to submit a product for approval through the section 505(b)(2) new drug application (NDA) can benefit from a less costly development program with the potential for a faster route to market than a traditional 505(b)(1) program.
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New FDA Guidance On Enhancing The Diversity Of Clinical Trial Populations, And Some Great Related Resources
12/10/2020
The FDA recently published a new guidance on diversity in clinical trial populations. Read the recommended approaches, and discover resources for learning more about the importance of diversity and inclusion of representative populations in clinical trials, as well as guides, toolkits, and other reference materials.
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505(b)(2) Regulatory Pathway: What Are The Advantages And Does Your Product Qualify?
11/23/2020
Over the past two decades, the development of drug products that fall somewhere “between” a brand new drug with a novel active ingredient and a pharmaceutically-equivalent generic drug (in other words, drugs that could qualify for a 505(b)(2) pathway) has grown extensively. This growth is due to the advantages offered by the 505(b)(2) pathway for more expeditious development of a new product, as well as the breadth of products that may qualify for this pathway.