House Trims 21st Century Cures Fat: Draft Bill Loses Half Its Weight
New discussion draft drops controversial exclusivity extensions and some other lesser-known ideas that may have benefited FDA and sponsors, but some placeholders still need to be filled.
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House Democrats say FDA will need more money to be able to handle the responsibilities in the draft bill, while the agency worries reviews could slow without more resources.
Hamburg’s departure from commissioner post seems to be proceeding smoothly; proposals in 21st Century Cures bill would mandate a similar process always be followed.
House 21st Century Cures discussion draft would adjust FDA promotion regulations for Twitter, requiring that information communicated through hyperlink be considered part of the original post.