The FDA is getting ready to implement regulatory changes laid out in the 21st Century Cures Act, reports Healio.
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.
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