Lowell Schiller, J.D., now the Chief Legal and Executive Officer at Aetion, discussed his views on RWE, the FDA, and science policy. Having previously worked for the FDA as Principal Associate Commissioner for Policy, as Acting Chief Counsel and as Senior Counselor to the FDA Commissioner, he has a unique understanding of the innerworkings of the FDA.
According to Schiller, the “FDA clearly recognizes the power of real-world evidence, and the agency has been working hard to ensure that the regulatory framework keeps pace with innovation. On the surveillance side, FDA’s been using a variety of real-world data for quite some time—for example, through the Sentinel System for monitoring medical product safety. We’re also seeing real-world evidence play an increasingly important role beyond safety surveillance, including in product approvals, such as to improve the efficiency of clinical studies or to supplement clinical trial data.” Learn more here.
(Source: Aetion, 1/14/21)