Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 93

The 21st Century Cures Act was passed by Congress and then signed into law on December 13, 2016. The stated intent of this legislation was to accelerate innovative medical product development and get advances to patients who need these products more efficiently.

The law encourages FDA to consider the perspectives of patients in FDA’ s decision-making process in medical product development. This encompasses innovation in drugs, therapeutic biologics, vaccines, and medical devices. The legislation encourages new approaches to scientifically-sound clinical trial designs and clinical outcome assessments.

The law also provides new authority to facilitate recruitment and retention of a broad base of highly qualified personnel to execute these innovative programs. The legislation contemplates new approaches to expedite innovation, including the following:

Regenerative Medicine Advanced Therapy (RMAT): This describes an expedited option for certain eligible biologics products;

The Breakthrough Devices Program: This is intended to speed the review of certain innovative medical devices.

In addition, this legislation directs FDA to create cross-center initiatives to coordinate activities in strategic areas, e.g., diseases with a major public health impact. These activities cascade to the regulation of combination products. It also establishes an FDA Oncology Center of Excellence (OCE), which supports patient-centered decision-making and an integrated approach to the evaluation of drugs, biologics, and devices medical products for the treatment of cancer. The OCE works with centers and offices across the FDA.

This Act authorized an additional US$ 500 million for FDA over 9 years to implement the legal requirements.