Golden Rice, the staple food genetically designed to contain beta carotene, a precursor to vitamin A, has been judged safe to eat by the US Food and Drug Administration (FDA). A letter from the FDA on May 24 stated that the agency had no further questions about the safety of the rice, originally developed to provide a rich source of vitamin A for children whose diets are deficient in this nutrient… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 36 NUMBER 7 JULY 2018…
An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology
Nikolay P. Nikolov and Marjorie A. Shapiro Abstract | Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for…