Expanded Access: FDA To Clarify How Adverse Events Impact Drug Approval Process
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.
You may also be interested in...
Expanded Access Data Supported Lutathera Approval, US FDA Notes
Amid broader debate on right-to-try legislation, review experience of Novartis' oncologic highlights US FDA's argument that expanded access can at least in part contribute to approval of a drug.
Right-To-Try Legislation Must Change Language To Narrow Spectrum Of Patients, Gottlieb Says
US FDA commissioner tells House hearing that the Senate's legislation in its current form could undermine the intent of addressing terminally ill patients.
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.