User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data
Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.
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User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases
House passes bill reauthorizing FDA user fee programs via voice vote and makes many other policy changes, but in the process touts the bill's potential to push drug prices lower.
Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says
New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.
Generic Priority Review Expanded In Senate User Fee Bill
Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.