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In a draft guidance Thursday, the FDA cautions that liposome drug products may respond to chemistry, manufacturing and control (CMC) changes with greater unpredictability than more conventional formulations. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More