US Food and Drug Administration Commissioner Robert Califf has given his strongest indication yet that the agency is ready to act unilaterally on diagnostic regulatory reform.
FDA Going Down ‘Pathway’ Of A Rule On LDTs, Califf Says
During a webinar hosted by the Alliance for a Stronger FDA, commissioner Robert Califf said the agency was on the path to using its rulemaking authority to regulate laboratory-developed tests.
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As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
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