Of 174 drugs and biologic therapies approved between January 2012 and December 2016, 105 (or 60%) traversed the FDA evaluation process with one of four designations aimed at speeding the path to ...

Drug Development Stages. Before the drug development process commences, scientists conduct computational studies, cellular assays, and genomic and proteomic research to identify a specific target ...

That's right, you're more likely to have 12 male children in a row than have a preclinical compound work its way through the drug development process and be approved by the FDA.

The intent of the FDA is to supposedly expedite the approval of safe drugs by fast-track designation. However, the bio-pharma companies investing in research and development to appease the strict FDA ...

Former FDA director Rob Califf, MD, addresses the Council for Entrepreneurial Development (CED) Life...[+] Science Conference in Raleigh, NC, February 28, 2017. Photo credit: David Kroll. David J ...

The U.S. Food and Drug Administration has launched a new effort to overhaul its application development governance process to provide management with visibility into the agency’s IT portfolio ...

The FDA Reauthorization Act of 2017 can designate drugs as a Competitive Generic Therapy if there is not more than one approved drug in the active section of the Orange Book.

The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project ...

In 1992, the FDA created the “accelerated approval” process, which allows drugs to go ahead with even earlier-stage data if they would be used to treat a life-threatening or serious illness.

The US Food and Drug Administration (FDA) is trying to improve how oncology drugs arrive in the clinic by making changes to the accelerated approval process, making a move towards optimal rather ...