RARE Act of 2018
Earlier this year, at the end of February, The Rare Disease Advancement, Research, and Education Act of 2018 (H.R.5115), or the RARE Act of 2018, was introduced into Congress. The goal of this bill is to [...]
Workshops held to discuss the use of Real World Evidence
The use of Real World Evidence (RWE) has expanded over the past decade. Real-world study designs are more efficient than before, sources of data collection have improved dramatically, and data analytic tools are increasingly able [...]
House of Representatives will vote again on national Right to Try bill
Last week, the US House of Representatives rejected the national Right to Try (RTT) bill, by a vote of 259-140. This bill, an earlier version of which was passed by Senate in August of last [...]
FDA and NORD collaborate on patient engagement initiative
In line with recently enacted legislation, including the 21st Century Cures Act, the FDA has been developing a number of programs to help bring the patient perspective to drug development and review processes. The FDA [...]
House rejects national RTT bill
On Tuesday the 13th of March, the US House of Representatives failed to pass the federal Right to Try (RTT) bill. This bill, which was passed by Senate in August of last year, would have [...]
Letter sent to Congress supporting Right to Try
Last month, WEP Clinical posted a blog article discussing a letter sent to Congress opposing Right to Try (RTT) legislation. Those responsible for drafting and sending the letter argue that RTT will do very little to improve [...]