ARTICLE | Politics, Policy & Law
FDA lays out right to try reporting requirements
July 24, 2020 11:33 PM UTC
Companies that provide an unapproved therapy to patients via the Right-to-Try Act would be required to report such instances to FDA, according to a rule proposed by the agency Thursday.
Under the rule, manufacturers would be required to submit an annual report to FDA that includes the number of doses supplied, the number of patients treated, what diseases the therapy was used to treat and any known serious adverse events...
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