The FDA is about to unveil an initiative to speed up the drug regulation process, according to a blog post by the agency’s new commissioner, Scott Gottlieb.
“FDA will soon unveil a comprehensive Innovation Initiative,” he wrote on the blog FDA Voice, according to a FierceBiotech report. “It will be aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion.
“We need to make sure that our regulatory principles are efficient and informed by the most up to date science,” Gottlieb added. “We don’t want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits.”
This will be undertaken mainly via the new processes coming out of the 21st Century Cures Act, signed into law last year, which gave the agency $500 million over the next nine years. The FDA says Cures is designed to speed up the regulatory process while taking into account the views of patients when it comes to drug development. The agency also wants to modernize clinical trial designs as well as clinical outcome assessments, which it hopes will help speed up the development and review of new meds.
Additionally, the act provides new authority to help the FDA create a series of new “expedited product development programs,” including Regenerative Medicine Advanced Therapy, that offer an additional accelerated option for certain biologics, and new institutes to help coordinate activities in major disease areas between the drug, biologics, and device centers and improve the regulation of combo products.
Gottlieb has now set out a “detailed work plan” for the steps the FDA is taking to implement different aspects of Cures.