FDA is “taking a number of new steps to support the development of high quality ANDAs for complex generic drugs,” writes Commissioner Gottlieb in a statement online. These steps include the release of a draft guidance describing an enhanced pathway toward formal discussions between FDA and ANDA submission applicants of complex products, and additional draft guidance intended to assist potential applicants in determining when an application for a synthetic peptide should be submitted as an ANDA. Materials on a series of scientific workshops that identify opportunities for complex generic drug development are available through the online statement.
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