Rob Lindberg, Ph.D., R.A.C., is the Center's BATON director. He holds a Ph.D. in Physiology and Biophysics. His specialty is microvascular physiology, with emphasis in endothelial function in inflammation, thrombosis and cancer.
Full Biography.
Orphan Drugs
Pharmaceutical and biological products targeting disease indications with a prevalence of under 200,000 patients in the U.S. may receive designation as an Orphan Drug from the FDA. This allows the opportunity for an expedited approval process (priority review) and conveys an extended period of marketing exclusivity (i.e., 7 years) to the sponsor. In addition, the fees typically paid to FDA for review of the NDA ($1,178,000 for 2008) are waived for products with orphan designation. These advantages are designed to encourage commercial development of important therapies for limited or underserved markets.
Medical Devices and Diagnostics
Sponsors seeking marketing approval for medical devices and in vitro diagnostic (IVD) tests used to guide therapeutic decisions typically enjoy a shorter (and less costly) development cycle (as compared with drugs or biologics), insofar as the requirement for clinical trials can be somewhat less demanding. Requests to initiate clinical development of medical devices are made to the CDRH in the form of an Investigational Device Exemption (IDE), which includes a comprehensive history of the design evolution of the device (Device Master File).
Upon completion of all required studies, device sponsors submit a Pre-Market Approval (PMA) application. Devices are categorizes with regards to their perceived safety risk to patients (Class I, II and III). In the event where CDRH recognizes a candidate device product as related to an existing approved (predicate) device, the candidate may receive 510(k) designation. Such devices are subject to fewer safety trials and a significantly shortened approval process. A challenge for developers of devices for which expedited 510(k) approval is sought is to successfully argue that the device is simultaneously novel (with regards to intellectual property protection) and yet substantially similar to an existing predicate device (as required for 510(k) designation).
Combination Products
Products that simultaneously employ two or more drug, biologic or device components (e.g., drug-device, drug – biological, biological-device) are subject to assignment to a primary regulating FDA Center (CDER, CBER or CDRH) by the FDA Office of Combination Products (OCP). The primary Center then oversees product review and regulation with support from the other relevant Center(s) as coordinated by OCP.