FDA plans to streamline regulatory processes for drugs, devices
FDA announced today that it will soon unveil a comprehensive plan referred to as the Innovative Initiative. The goal of the initiative is to ensure the efficacy of the FDA’s regulatory processes so 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,” Scott Gottlieb, MD, commissioner of the FDA, wrote in the FDA’s blog. “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.”
To streamline regulatory processes and cost effectiveness, the FDA will implement the new authorities and resources granted to the agency by the 21st Century Cures Act.
“FDA is working hard to maximize the authorities and resources Congress granted us to advance medical innovation for patients,” Gottlieb commented. The agency has established an intra-agency Cures Steering Committee that has conducted a detailed analysis of the law’s provisions. A compiled list of all FDA-related requirements is available on the agency’s site.
With the opportunities afforded by the Cures act, the FDA has announced the following plans and recent efforts:
1. The FDA will implement the silico tools in clinical trials. Silico clinical trials use computer models and simulations to develop and evaluate devices and drugs, which will advance safety and efficacy testing and improve product development.
2. The Center for Biologics Evaluation and Research is implementing the Regenerative Medicine Advanced Therapy, or RMAT designation, to provide an additional pathway to expedite programs for certain cell therapies, tissue engineering products and combination products.
3. The recently launched Oncology Center of Excellence will focus on a specific disease area rather than a type of product and take advantage of coordinating the clinical review of products across FDA drug, device and biologic centers.
4. The Center for Drug Evaluation and Research recently exempted more than 70 Class I device types from the requirement to submit a 510(k) application to the FDA and has proposed exempting an additional 1,000 or more Class II device types. This effort is based on an initial determination that premarket reviews are not necessary to provide reasonable assurance of safety and efficacy.
5. The Center for Devices and Radiological Health recently amended its current regulations to allow more devices to qualify for humanitarian device exemption for small patient populations, which will go into effect on Aug. 8, 2017.
6. The Center for Drug Evaluation and Research recently issued a plan with the Center for Biologics and Research to develop and issue patient-focused drug development guides.
“We’re at the beginning of a transformative era in science and medical technology. Through our implementation of Cures, and our efforts to build on its provisions through a new Innovation Initiative, we hope that our collective efforts will help consumers benefit from this new progress,” Gottlieb concluded. “FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law — both its letter and its spirit.” – by Talitha Bennett