Rare disease developers applaud clarity in FDA guidance [Yahoo! Finance]
INNOVATIVE DESIGNS INC (IVDN)
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Source: Yahoo! Finance
US Food and Drug Administration (FDA) over the past year, have delivered much-needed clarity on regulatory expectations, including what is and what is not permissible. Since the Trump administration took office in January 2025, with Robert F. Kennedy Jr (RFK Jr) assuming the position of Health Secretary, there have been several changes in the FDA, including the release of some notable draft guidance documents for rare disease developers. While experts broadly agree that the FDA has always been receptive and open to rare disease developers in the past, it has generally been on a case-by-case basis, making it difficult for sponsors to be sure the agency will be satisfied with a trial design. One notable example is Disc's bitopertin - a treatment for erythropoietic protoporphyria (EPP), which faced regulatory scrutiny after the agency raised concerns about the company's use of a surrogate endpoint. As a result, the draft guidance documents, including the “ Rare Disease Evidence Pat
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