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Samantha Hoopes
Blog Post

505(b)(2) vs ANDA: How Complex Drugs Fit In

While it is important to understand how to navigate the complex generic drug approval pathway, it is first necessary to determine whether your drug product should be submitted as an abbreviated new drug application (ANDA) for approval as a generic or if it requires submission of a 505(b)(2) new drug application. This particular issue is addressed in a draft guidance “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” Our blog will help you understand when a 505(b)(2) application is appropriate and when an ANDA is appropriate.

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

North American Cystic Fibrosis Conference: Key Takeaways

The 33rd Annual NACF conference continues to be an action packed 3 days bringing together scientists, clinicians, health care providers, and caregivers to discuss the latest advances in CF research, care, and drug development.  These are our top 3 takeaways from the meeting and how they will impact clinical research moving forward.

Meagan Spychala
Blog Post

Patient-Focused Drug Development: Incorporating the Patient’s and Caregivers’ Perspectives into Product Development

Patient-centricity and family-centricity has been a hot topic for the past few years in clinical research, as more groups in pharmaceutical companies and CROs are working on patient engagement and patient-centric approaches to clinical research programs. Recruitment and retention are one part of patient-centricity, but the more important up-front and overarching aspect of patient-centric research comes from Patient-Focused Drug Development (PFDD).

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?