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The FDAs staff reviewers had last month said there is little evidence to support the safety and effectiveness of these peptides for their intended uses and flagged a lack of adequate human clinical trials, in contrast to Kennedys public support

Serrao R, Zirwas M, English JC

Insurance coverage gaps, high co-payments, and out-of-pocket expenses also impact patient adherence even in developed countries

CMS did not finalize additional elements suggested, such as data at the PDE record level, after weighing whether any such additional information fulfilled CMS' statutory obligation and the potential benefits to manufacturers against the administrative burdens additional reporting would impose on the agency and operational feasibility