Zdrowie i gospodarka · 03/12/2008

FDA Releases Draft Guidance on Patent Information for Old Antibiotics

The Food and Drug Administration (FDA) has made available a draft guidance document outlining its approach to implementing patent provisions related to old antibiotics, specifically targeting sponsors of new drug applications (NDAs) that must submit patent information by December 5, 2008, as mandated by the Q1 Program Supplemental Funding Act.