The United States Food and Drug Administration (FDA) released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases, Outsourcing-Pharma.com reports. FDA collaborated with the European...
Melissa Fassbender’s recent article on Outsourcing Pharma tells us that diabetes drug development is riskier than most other drug development according to Tufts Center for the Study of Drug Development. Fassbender’s article has the data from Tufts’ study to share. ...
23andMe, a DNA analysis service company who provides information and tools to individuals to learn more about their DNA has announced its plan to invent its own drugs using customer data. This drastic move will allow 23andMe to capitalize on the economic value its...
Last month at Partnerships in Clinical Trials (PCT) in Barcelona, Spain, TransCelerate Biopharma CEO, Dalvir Gill explained to contract research and pharma industry representatives that working together to fix issues is the key to simplifying and expediting the...
Centerwatch.com produced an interesting article on the implementation of new strategies to improve drug developer’s access to comparator drugs for clinical testing. The article brings to light the difficulty of obtaining comparator drugs, with the Tufts Center for...
We are looking for a new talent to join the Pearl team. Effective immediately, Pearl Pathways in Indianapolis, Indiana has a new position open for a Regulatory Publication Coordinator. Please see the job description online here. Experience with eCTD for an NDA or...