FDA Drug Safety Board Will Impact All "Medical Product" Activities, Crawford Says
This article was originally published in The Pink Sheet Daily
Commissioner plans to appeal to the House appropriations subcommittee for additional funding of agency programs.
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The board discussed FDA's recent action on fentanyl transdermal patches (J&J's Duragesic and generics) and Purdue's Palladone (hydromorphone extended-release) during a July 27 meeting, FDA's meeting summary says.
FDA Commissioner Crawford defends the board as an "instrument of openness" in response to complaints that the panel's closed proceedings will fail to provide greater transparency.
Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.