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Development of COVID-19 Therapies: FDA Pathways

At a high level, there are basically 3 (inter-related) programs that FDA has in place to make drug product available for COVID-19 patients in an expedited manner or under an “emergency” use status for products that are ready to initiate clinical studies, are already undergoing clinical development prior to approval of a new drug application, or are already approved in other indications: CTAP, EUA and Expanded Access.

Monica Frazier
Blog Post

COVID-19 FDA Response: Guidance Released for Conduct of Ongoing Trials

This blog post serves as an introduction to a series of posts related to maintenance of the reliability and validity of ongoing clinical trial data during the COVID-19 pandemic. The FDA Guidance on conduct of clinical trials of medical products during the COVID-19 pandemic, released initially on March 18th and updated on March 27th (with questions and answers), provides support for industry, investigators, and Institutional Review Boards (IRBs) managing these new challenges.

Blog Post

Four Considerations for Rare Disease Drug Development Programs

Rho representatives joined regulators, industry scientists, and numerous patient-advocacy groups at CBI’s Rare Disease Clinical Development and Access Summit in Washington. Attendees were able to share best practices in product development for rare disease programs in formal presentations and through informal networking. Here are 4 considerations for your development program that were highlighted during the conference.

Blog Post

Is a Target Product Profile Worth the Effort?

Perhaps the greatest value of the TPP is as a communication tool. The ultimate goal of the development program is shared clearly and continually with all the company disciplines, e.g., clinical, preclinical, chemistry manufacturing and controls, regulatory, and marketing. The TPP is also able to be used as an external communication tool that facilitates interactions with regulatory authorities, investors, and the media.

Joseph Watson
Blog Post

Orphan Drug Development and Single Trials

Since the enactment of the Orphan Drug Act in 1983, the number of orphan drug approvals has risen steadily. Rho has received an increasing number of sponsor requests for support of programs working towards an orphan drug approval. Can a product be approved with support from a single trial? To better understand when a single trial approval is possible, we look to FDA guidances.

Blog Post

FDA’s Project Orbis: Trendsetter or One-off

With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. Is this the tip of the iceberg for process improvement?

Kevin Barber
Blog Post

Master Protocols and the New FDA Guidance

In September of 2018, FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges? Kevin Barber shares his thoughts and expertise on the topic.