by Marc Kleinman | Feb 23, 2012
In January, the British Medical Journal (BMJ) published an article claiming that only 163 of the 738 clinical trials subject to mandatory reporting on ClinicalTrials.gov had actually registered results. That’s just 22%, as compared to trials not required to register...
by Marc Kleinman | Feb 17, 2012
On Monday FDA released a $4.5 billion budget request for 2013, which represents a 17% (or $654 million) increase over its current budget. The request, which is part of the White House’s $3.8 trillion federal budget proposal, includes a dramatic increase in industry...
by Marc Kleinman | Feb 14, 2012
FDA recently released a set of 3 draft guidance documents related to the development of biosimilar products—a biological product (vaccine, protein, tissue, blood or blood component, gene therapy, etc.) that is highly similar to a reference product previously approved...
by Marc Kleinman | Feb 9, 2012
FDA’s Center for Devices and Radiological Health (CDRH) recently released its 2012 Strategic Priorities, which includes a number of new initiatives and pilot programs designed to improve regulatory pathways and compliance processes as well as support new device-based...
by Marc Kleinman | Jan 30, 2012
Pearl Pathways serves the start up drug and device sector happily. When we work with founders and the small management teams of start ups, it is some of the most rewarding work we do. However, it’s no secret that early stage venture funding for biotechs has fallen...