Draft guidance for antibiotics focuses on superiority
This is the backdrop of the draft guidance released in July 2013, which has received additional attention after FDA is focusing on bacterial products. The draft guidance in discussion is Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Diseases.According to the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) — regarding the Generating Antibacterial Incentives Now (GAIN) Act—FDA received additional authority to grant additional terms for exclusivity of marketing and such other incentives or provisions, to the products related to antibacterial and antifungal products that are developed to treat known infectious diseases.
According to the US pharmaceutical industry, this guidance issued by the US Food and Drug Administration (FDA) aims at encouraging the development of new antibacterial therapies focuses too much on superiority studies. In this issue, the legitimate needs and uses are being advancing antimicrobial resistance to existing therapies.
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