FDA Unveils Regulatory Science Progress Report

The report, covering the years 2015 and 2016, points to significant progress in the US Food and Drug Administration (FDA) in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and Improvement of the internal computer tools to support the applications of regulation of scientific examination.

In the clinic

As for non-clinical predictors, the report indicates that FDA researchers have developed a variety of software tools that are now compatible with the non-clinical evaluation of medical products.

"These tools include sophisticated models to predict the carcinogenic effects of some of the ingredients of drugs based on their structural attributes, mathematical representations of the human body (IT ghosts) that can be used to predict the effects of medical devices, such as Radiation exposure, and mechanically-informed pharmacokinetic models to help predict drug exposure in populations where it is difficult to obtain clinical data, "according to the report.

The FDA has also developed in vitro methods and tools to better understand the properties of drugs and biologicals, including vaccines and new tools to support the assessment and development of medical imaging technologies.

Genetic approaches and transplantation have also been used to create animal models that aim to predict the human response more deeply to medical products, and new physical methods and procedures have been developed to support generic bioequivalence assessment of generic drugs.

Clinical evaluation

To better support clinical evaluation of medical products, the FDA engages in the development and evaluation of biomarkers to better predict long-term treatment outcomes or to affect certain patients more likely to be successful treatments.

For example, the FDA notes that its statisticians helped design antibiotic trials that could assess factors related to the development of resistant microorganisms.

In addition, the agency has formed new biomarkers to guide treatment decisions and predict the progression of the disease.

"A long-term research effort to improve cardiovascular risk prediction contributed to the recommendation of the International Conference on Harmonization that the cost-intensive and resource-intensive QT study (required to assess the majority of candidates To drugs) could be replaced by an electrocardiogram - measures based on early-stage clinical studies, "the report said.

He also referred to the FDA's efforts regarding the use of real-world evidence, staff members have expressed concerns in the past.

Through initiatives such as the patient-centered drug development initiative, the Advisory Committee on Patient Commitment to Healthcare Products and the Patient Preferential Initiative, the FDA also incorporates patient views into the Development and evaluation of medical products.

Manufacturing and Quality

The FDA's medical product centers also address scientific issues related to new critical technologies for the manufacture of products to improve the reliability of drug delivery, complex product characterization, quality standards, Approval of product quality and understanding of interactions of regulated products with products of biological systems.

"We have developed the in-house laboratory and computing capabilities to study continuous production with an advanced process control system," the report added. "We have worked with the Biomedical Research and Development Authority (BARDA) to take advantage of continuous manufacturing to minimize vulnerability to domestic, biological and radiological chemistry. We have set in motion the creation of a 3-D printing to understand the factors Which contribute to quality and quality, the performance of implantable medical devices, drugs and combined products made with this new technology.

In addition, the FDA has developed automated approaches to predict critical properties of human stem cell preparations, such as their ability to contribute to bone growth.

Illinois

The agency has launched its "JumpStart" service that allows evaluators to organize, manage and verify the quality of clinical data in ap