FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors
New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.
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Senate passage of the FDA user fee package without amendments was enabled by unanimous consent votes on controversial right-to-try legislation that is toned down from its initial version, as well as two other bills.
GAO says lack of clear information from FDA may influence whether manufacturers grant expanded access to investigational drugs; only two clinical holds have been due to adverse events from expanded access use.