MDUFA V Passed By US House Health Subcommittee
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.
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The legislative package, which sets user-fee amounts through 2027, funds a bevvy of FDA activities and improvements.
The US agency is re-evaluating its criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs. A 2014 guidance on cord blood products could serve a template, industry suggests.
US House of Representatives Energy and Commerce committee ranking member Rep. Cathy McMorris-Rodgers, R-WA, raised questions about the $3bn earmarked for new health research agency ARPA-H during user fee hearings on 11 May.