Generating Antibiotic Incentives Now (GAIN) and the Qualified Infectious Disease Product (QIDP) designation and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), described below, were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective therapies.
Over a three year period, Rho and Anthera Pharmaceuticals developed a collaborative partnership developing a product to treat Cystic Fibrosis. Some highlights of the partnership included: Expanding the scope of
How can we ensure that successful clinical trial interventions will lead to long-term improvements in healthcare? Novel research and information dissemination projects like the CHAMPS program offer promise for bridging the gap between clinical trials and health practice.
What is gene therapy? With over 450 gene therapy and gene-based medicine companies worldwide and around 800 gene therapy and gene-modified cell therapy clinical trials being conducted, it’s time to find out.
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.
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.
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?
